{ "title": "Enclomiphene evidence census (Condor Research Evidence Card)", "version": "1.0-rc", "cutoff": "2026-10-17", "license": "CC BY 4.0", "publisher": "Condor Research Editorial", "conflict_of_interest": "Condor Research sells enclomiphene as a research-use-only compound.", "how_to_cite": "Condor Research Editorial. Enclomiphene Evidence Card, version 1.0-rc, data cut-off 2026-10-17. https://condorresearch.com/research/what-is-enclomiphene/", "method": "PubMed E-utilities on all PubChem-verified synonyms; every record hand-classified from title/abstract; 40-record blind double coding. ClinicalTrials.gov API v2, keeping only records that name the compound.", "data_dictionary": { "records[].model": "in_vitro | animal | human (people enrolled) | review | chem_analytical | commentary | modelling | other", "records[].role": "E isolated enclomiphene | COMBO isolated enclomiphene within a multi-ingredient product | ISO isomers compared | MIX clomiphene mixture | SEC secondary literature | ZU actually zuclomiphene | OTHER tangential", "records[].origin": "SP Repros Therapeutics author | SD Repros-sponsored trial data without Repros authors | IN no link visible in the record", "records[].country": "country of the first affiliation in the PubMed record; NR = no affiliation in the record", "records[].label_pre_1977": "uses cis/trans labels before the 1976 stereochemical correction (PMID 1255423)", "trials[].category": "efficacy | safety | pk, from the registered title and primary endpoint", "trials[].pubmed_certainty": "identifier = NCT number or ZA code in the article; design and arm sizes = matched from full text", "trials[].primary_result": "summary without doses; source in result_source", "metrics": "every number quoted on the page; units are in the key names (articles, trials, enrolments)", "text_tables": "every table printed on the page, as rows" }, "pubmed_query": "enclomiphene[all] OR \"trans-clomiphene\"[tiab] OR transclomiphene[tiab] OR \"trans-clomifene\"[tiab] OR androxal[tiab] OR enclomid[tiab] OR \"en-clomiphene\"[tiab] OR \"E-clomiphene\"[tiab] OR \"(E)-clomiphene\"[tiab] OR \"clomiphene B\"[tiab] OR \"trans-clomiphene citrate\"[tiab]", "ctgov_queries": { "query.term=enclomiphene": { "totalCount": 285, "date": "2026-10-17" }, "query.intr=enclomiphene": { "totalCount": 262, "date": "2026-10-17" }, "query.term=Androxal": { "totalCount": 285, "date": "2026-10-17" }, "query.intr=Androxal": { "totalCount": 262, "date": "2026-10-17" }, "query.term=trans-clomiphene": { "totalCount": 278, "date": "2026-10-17" }, "query.intr=trans-clomiphene": { "totalCount": 258, "date": "2026-10-17" }, "query.term=enclomiphene citrate": { "totalCount": 257, "date": "2026-10-17" }, "query.intr=enclomiphene citrate": { "totalCount": 234, "date": "2026-10-17" }, "query.term=enclomifene": { "totalCount": 285, "date": "2026-10-17" }, "query.intr=enclomifene": { "totalCount": 262, "date": "2026-10-17" }, "query.term=Enclomid": { "totalCount": 0, "date": "2026-10-17" }, "query.intr=Enclomid": { "totalCount": 0, "date": "2026-10-17" }, "query.term=zuclomiphene": { "totalCount": 285, "date": "2026-10-17" }, "query.intr=zuclomiphene": { "totalCount": 262, "date": "2026-10-17" }, "union_returned": 285, "literal_mention": 29 }, "excluded_trials": { "NCT02644304": "clomiphene trial; enclomiphene only in background text", "NCT03028532": "clomiphene (Clomid) anti-doping PK study", "NCT03646162": "VERU-944 = zuclomiphene citrate (other isomer), men with prostate cancer", "NCT05096169": "clomiphene citrate, withdrawn" }, "metrics": { "version": "1.0-rc", "cutoff": "2026-10-17", "pubmed_records": 107, "pubmed_query_counts": { "E_enclomiphene_specific": 107, "Z_zuclomiphene": 58, "C_clomiphene_all": 7653, "C_clomiphene_RCT": 582, "C_clomiphene_clinical_trial": 875, "C_clomiphene_male": 2031, "C_clomiphene_male_hypogonadism": 368, "E_RCT_pt": 3, "E_clinical_trial_pt": 7, "E_review_pt": 8, "ISOMER_B_discarded": 107, "ISOMER_B_with_clomiphene": 0 }, "by_model": { "animal": 41, "in_vitro": 21, "human": 17, "review": 11, "chem_analytical": 8, "commentary": 7, "other": 1, "modelling": 1 }, "by_role": { "ISO": 41, "E": 33, "SEC": 17, "MIX": 9, "OTHER": 4, "ZU": 2, "COMBO": 1 }, "by_origin": { "IN": 100, "SP": 6, "SD": 1 }, "by_decade_model": { "1970s": { "animal": 12, "in_vitro": 1 }, "1980s": { "animal": 18, "in_vitro": 13, "chem_analytical": 1, "human": 1 }, "1990s": { "in_vitro": 4, "animal": 7, "human": 2, "chem_analytical": 3 }, "2000s": { "in_vitro": 2, "animal": 2, "other": 1, "review": 3, "chem_analytical": 2, "human": 3 }, "2010s": { "human": 7, "commentary": 4, "animal": 1, "review": 2, "in_vitro": 1, "chem_analytical": 1 }, "2020s": { "review": 6, "modelling": 1, "human": 4, "animal": 1, "chem_analytical": 1, "commentary": 3 } }, "records_since_2009": 37, "records_since_2009_by_model": { "human": 13, "review": 10, "commentary": 7, "chem_analytical": 3, "animal": 2, "in_vitro": 1, "modelling": 1 }, "pre_1977_cis_trans_labels": 10, "first_affiliation_known": 66, "countries": { "USA": 37, "UK": 7, "India": 3, "Sweden": 2, "China": 2, "Brazil": 2, "Portugal": 1, "Israel": 1, "Belgium": 1, "Taiwan": 1, "Spain": 1, "Japan": 1, "South Korea": 1, "Germany": 1, "Italy": 1, "Canada": 1, "France": 1, "Slovakia": 1, "Pakistan": 1 }, "human_articles": 17, "human_articles_by_role": { "MIX": 8, "E": 7, "ISO": 1, "COMBO": 1 }, "articles_enclomiphene_given_to_men": 8, "articles_enclomiphene_alone_in_men": 7, "articles_enclomiphene_combination_in_men": 1, "articles_isomer_comparison_in_women": [ "2497133" ], "controlled_articles_in_men": [ "23530575", "23875626", "25044085", "26496621" ], "controlled_trials_in_those_articles": 5, "controlled_articles_by_origin": { "SP": 3, "SD": 1 }, "uncontrolled_articles_by_origin": { "IN": 4 }, "enrolment_as_reported": { "23875626": { "article_text": 48, "article_arm_counts_sum": 60, "registry_ZA-204": 60 }, "23530575": { "article": 12, "registry_ZA-201": 17 }, "25044085": { "article_enrolled": 124, "article_randomised": 120, "article_completed": 73, "registry_ZA-203": 83 }, "26496621": { "itt": 256, "itt_ZA-304": 129, "itt_ZA-305": 127, "per_protocol": 217, "registry_ZA-304_plus_ZA-305": 240 } }, "fulltexts_read": 11, "ct_returned_by_search": 285, "ct_naming_compound": 29, "ct_interventional_enclomiphene": 25, "ct_by_category": { "efficacy": 10, "pk": 8, "safety": 7 }, "ct_sponsor": 24, "ct_sponsor_completed": 24, "ct_enrolment_actual_sum": 2171, "ct_journal_article_by_identifier": 3, "ct_journal_article_total": 5, "ct_journal_article_pct_range": [ 12.5, 20.8 ], "ct_results_posted": 10, "ct_results_posted_pct": 41.7, "ct_posted_or_article": 12, "ct_epar_summary_only": 12, "ct_no_public_results": 0, "ct_years_since_completion_without_posted_results": [ 11.8, 12.1, 12.1, 12.2, 12.2, 12.2, 12.2, 12.2, 12.4, 12.5, 12.8, 13.8, 19.4, 19.4 ], "sensitivity": { "records_excluding_label_reversed_ZU": 105, "records_excluding_pre_1977_labels": 97, "articles_given_to_men_excluding_combination": 7, "articles_given_including_isomer_comparison_in_women": 9, "controlled_articles_sponsor_if_Kim2016_coded_independent": 3, "publication_rate_identifier_only_pct": 12.5, "publication_rate_all_matches_pct": 20.8, "results_anywhere_incl_EPAR_summary_pct": 100.0, "journal_article_identifier_only": 3 }, "double_coding": { "n": 40, "seed": 20261017, "share_of_census_pct": 37.4, "variables": { "model": { "percent_agreement": 100.0, "cohen_kappa": 1.0 }, "role": { "percent_agreement": 97.5, "cohen_kappa": 0.97 }, "origin": { "percent_agreement": 100.0, "cohen_kappa": 1.0 } }, "disagreements": [ { "pmid": "6781360", "role": { "coder1": "ISO", "coder2": "E" }, "coder2_note": "pituitary cells; Clomid and enclomid tested" } ], "adjudication": { "6781360": "role E (Clomid vs enclomiphene vs tamoxifen; zuclomiphene not tested). Applied in classification.py after the comparison." }, "coders": "Both coders are language-model instances (Claude) working from the same codebook; coder 2 was a separate session that saw only the codebook and the 40 records, not coder 1's codes." } }, "text_tables": [ { "id": "index", "n": 1, "caption": "Table 1. The Condor Evidence Index row for enclomiphene before and after the hand recount (units in the first column).", "columns": [ "Field (unit)", "Automated value", "Recounted 2026-10-17", "What changed" ], "rows": [ [ "PubMed articles, all synonyms", "208", "107", "The PubChem synonym \"ISOMER B\" retrieves 107 PubMed records, none about clomiphene. Removed." ], [ "Articles that enrolled people", "60", "17", "The old value used the MeSH filter humans[mh], which also tags human cells and tissue." ], [ "Articles with PubMed type \"Clinical Trial\"", "0", "7", "3 also carry \"Randomized Controlled Trial\"." ], [ "ClinicalTrials.gov records", "282", "29", "The registry expands terms to clomiphene; only records naming the compound are kept." ], [ "Interventional enclomiphene trials", "259", "25", "24 sponsored by Repros Therapeutics (all completed); 1 academic trial withdrawn before enrolment." ] ] }, { "id": "human", "n": 2, "caption": "Table 2. PubMed articles in which men received enclomiphene: 8 articles (7 with enclomiphene alone, 1 with a multi-ingredient product) reporting 9 trials or case series, since Kim 2016 reports two trials, plus the one isomer-comparison study in women, listed separately. Doses and regimens are deliberately omitted. Enrolled = all arms.", "columns": [ "Article", "Design", "Enrolled", "Duration", "Primary endpoint", "Reported result", "Link to developer" ], "rows": [ [ "Wiehle 2013 (ZA-204, matched){{r:23875626}}", "Randomised, single-blind, two-centre Phase 2, vs testosterone comparator", "48 in the text; arm counts 16 + 14 + 16 + 14 = 60 (registry: 60)", "6 weeks", "24-hour testosterone and LH profiles", "Testosterone rose, not different from comparator (p = 0.23); LH rose with enclomiphene and was suppressed by the comparator", "6 of 9 authors at Repros; the conflict statement reads \"None declared\"" ], [ "Kaminetsky 2013 (ZA-201, matched){{r:23530575}}", "Randomised, open-label, two-centre Phase 2b, vs testosterone comparator", "12 (arms of 7 and 5); registry: 17, with a third arm not in the article", "6 months plus follow-up", "Testosterone, LH, FSH, semen", "Testosterone similar between arms; sperm counts rose only with enclomiphene; authors note the small sample limits conclusions", "2 Repros employees and stockholders (declared)" ], [ "Wiehle 2014 (ZA-203, NCT01270841){{r:25044085}}", "Randomised Phase 2b, double-blind for enclomiphene vs placebo, open-label comparator", "124 enrolled, 120 randomised, 73 completed (registry: 83)", "3 months", "Change in morning total testosterone", "Rose vs placebo, similar to comparator; sperm counts conserved", "5 Repros authors; one declares a trans-clomiphene patent; the Baylor co-author declares Repros consultancy" ], [ "Kim 2016 (ZA-304 and ZA-305){{r:26496621}}", "Two randomised, double-blind, double-dummy Phase 3 trials, placebo and testosterone comparator", "256 ITT (129 + 127), 217 per protocol (registry: 120 + 120)", "16 weeks", "Composite: testosterone in range and sperm at least 10 million/mL", "Met in both: 61.0% and 65.9% vs 16.3% and 33.3% on the comparator and 4.4% and 7.3% on placebo (EPAR; see note on ZA-305); pooled in the article 63.5% vs 24.7% vs 5.8%. No patient-reported outcome reported{{r:EPAR}}", "Sponsor trials; two authors declare Repros consultancy; data assembled by Repros staff" ], [ "Thomas 2023{{r:37546076}}", "Retrospective cohort, enclomiphene vs clomiphene", "46 + 32", "At least 3 months", "Testosterone and semen parameters", "Testosterone rose in both; LH, FSH and total motile count rose only with enclomiphene", "None visible (University of Miami)" ], [ "Saffati 2024{{r:39434750}}", "Retrospective, same men switched from clomiphene to enclomiphene", "66", "Variable", "Testosterone change; recorded adverse effects", "Testosterone difference not significant (p = 0.20); fewer recorded adverse effects with enclomiphene", "No Repros link declared in 2024; a co-author declared Repros consultancy in 2014 and 2016 articles{{r:25044085}}{{r:27337642}}" ], [ "Warren 2026{{r:42170362}}", "Retrospective case series of a compounded multi-ingredient product (combination)", "15", "60 days", "Change in total testosterone", "Rose in all 15; no control group; enclomiphene effect not separable from the other ingredients", "None with Repros; author declares later ties to the product's licensee" ], [ "Tariq 2026{{r:42741668}}", "Case report", "1", "n/a", "Atrial flutter newly detected during enclomiphene exposure (case report)", "Causality rated \"possible\" (Naranjo)", "None" ], [ "Glasier 1989{{r:2497133}} (not counted above)", "Isomer comparison in women: clomiphene cycle, then E or Z isomer alone", "19", "Single cycles", "Follicular development", "Increased with the E isomer and with clomiphene; not with the Z isomer", "None (University of Edinburgh)" ] ] }, { "id": "census", "n": 7, "caption": "Table 7. The 107 PubMed articles by model. \"Human\" means people were enrolled; experiments on human cells or tissue count as in vitro.", "columns": [ "Model", "Articles", "Share", "Notes" ], "rows": [ [ "Animal", "41", "38%", "Mostly rats; also ewes, cows, guinea pigs, a bat, a fish, zebrafish. 37 of 41 published before 2000." ], [ "In vitro", "21", "20%", "Receptor binding, pituitary and granulosa cells, cancer cell lines, liver microsomes." ], [ "Human (people enrolled)", "17", "16%", "8 give enclomiphene to men (7 alone, 1 combination); 1 compares isomers in women; 8 concern the clomiphene mixture." ], [ "Review", "11", "10%", "Includes 2 systematic reviews with meta-analysis." ], [ "Chemistry / analytical", "8", "7%", "Isomer separation, binding chromatography, solid-state physics." ], [ "Commentary, letters, position statements", "7", "7%", "Includes the 2026 British Society of Sexual Medicine position statement." ], [ "Modelling and other", "2", "2%", "One PBPK model; one LactMed database entry." ] ] }, { "id": "isomers", "n": 8, "caption": "Table 8. Identity and comparative pharmacokinetics of the two isomers, as reported in the cited sources. PK rows come from different populations and designs and are not directly comparable.", "columns": [ "Property", "Enclomiphene (E)", "Zuclomiphene (Z)", "Source" ], "rows": [ [ "PubChem CID", "1548953 (base); 6420009 (citrate)", "1548955", "PubChem{{r:PUBCHEM}}" ], [ "CAS", "15690-57-0 (base); 7599-79-3 (citrate)", "15690-55-8", "PubChem" ], [ "Formula / molar mass", "C26H28ClNO, 406.0 g/mol; citrate C32H36ClNO8, 598.1 g/mol", "C26H28ClNO, 406.0 g/mol", "PubChem" ], [ "InChIKey", "GKIRPKYJQBWNGO-OCEACIFDSA-N", "GKIRPKYJQBWNGO-QPLCGJKRSA-N", "PubChem" ], [ "Names", "enclomifene (INN), enclomiphene (USAN), trans-clomiphene, (E)-clomiphene, Androxal, EnCyzix, RMI 16,289", "zuclomifene (INN), cis-clomiphene, (Z)-clomiphene", "PubChem; EMA" ], [ "Share of clomiphene citrate", "50-70% (label range); about 62% in commercial clomiphene described in 1986 and 1993", "30-50% (label range); about 38%", "US label{{r:CLOMIDLABEL}}; Mikkelson 1986{{r:3091405}}; Adashi 1993{{r:8358894}}" ], [ "Reported plasma elimination", "t1/2 8 to 10 hours", "Not quantified: described as an unexpectedly long half-life with plasma levels detectable up to a month (healthy women); terminal phase too flat to model (women with PCOS)", "EMA EPAR{{r:EPAR}}; Mikkelson 1986{{r:3091405}}; Ghobadi 2009{{r:19033451}}" ], [ "Time to peak after a single exposure (healthy women)", "Earlier than Z", "About 6.5 hours", "Mikkelson 1986" ], [ "Plasma ratio E:Z after a single exposure", "About 1:1 at 2 hours", "Over 1:6 at 24 hours", "Mikkelson 1986" ], [ "Across repeated clomiphene cycles (women)", "Undetectable before each new cycle", "Detectable from cycle 2, rising over three to four cycles, then a plateau", "Young 1999{{r:10202872}}" ], [ "Serum levels after at least 6 weeks of clomiphene exposure (men, n = 15)", "Median 2.2 ng/mL", "Median 44.0 ng/mL (range 27.6 to 109.0); median Z:E ratio about 20 (21.3 in the accepted manuscript)", "Helo 2017{{r:27511863}}; isomer assays run by Repros" ], [ "Estrogenic activity", "Lower", "Greater (\"some data suggest\")", "US label; Jordan 1981{{r:6781873}}" ] ] } ], "records": [ { "pmid": "4940071", "year": 1970, "title": "Contrasting actions of cis- and trans-clomiphene on the release of FSH and FSH-RF in the female rat.", "journal": "Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme", "doi": "10.1055/s-0028-1095051", "authors": [ "Nagel S", "Baier H", "Taubert HD" ], "first_affiliation": null, "model": "animal", "design": "rat endocrine", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": true, "note": "cis vs trans on FSH release, female rat; no abstract", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/4940071/" }, { "pmid": "5074580", "year": 1972, "title": "The effect of cis- and trans-clomiphene citrate on the collagen content of fetal bone.", "journal": "Toxicology and applied pharmacology", "doi": "10.1016/0041-008x(72)90195-0", "authors": [ "Souma JA", "Marshall LD", "Abdul-Karim RW" ], "first_affiliation": null, "model": "animal", "design": "fetal bone collagen", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": true, "note": "no abstract", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/5074580/" }, { "pmid": "4721294", "year": 1973, "title": "Effects of cis- and trans-clomiphene in the induction of sexual behavior.", "journal": "Endocrinology", "doi": "10.1210/endo-93-3-681", "authors": [ "Ross JW", "Paup DC", "Brant-Zawadzki M", "Marshall JR", "Gorski RA" ], "first_affiliation": null, "model": "animal", "design": "sexual behaviour", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": true, "note": "no abstract", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/4721294/" }, { "pmid": "4752137", "year": 1973, "title": "The effect of cis- and trans-clomiphene citrate on sialic acid in the uterus, cervix and vagina of rats during delayed implantation.", "journal": "Journal of reproduction and fertility", "doi": "10.1530/jrf.0.0350203", "authors": [ "Sankaran MS", "Prasad MR" ], "first_affiliation": null, "model": "animal", "design": "rat delayed implantation", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": true, "note": "no abstract", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/4752137/" }, { "pmid": "4779289", "year": 1973, "title": "Changes in fructose & citric acid in accessory glands of reproduction of rats following long-term treatment with isomers of clomiphene citrate.", "journal": "Indian journal of experimental biology", "doi": null, "authors": [ "Singh SP", "Prasad MR" ], "first_affiliation": null, "model": "animal", "design": "rat male accessory glands", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": true, "note": "indexed by MeSH only", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/4779289/" }, { "pmid": "4779300", "year": 1973, "title": "Studies on physiology & biochemistry of female genital tract: response of uterus, cervix & vagina of albino rats to cis- & trans-clomiphene in the presence or absence of estrogen.", "journal": "Indian journal of experimental biology", "doi": null, "authors": [ "Karkun JN", "Mehrotra PK" ], "first_affiliation": null, "model": "animal", "design": "rat genital tract", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": true, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/4779300/" }, { "pmid": "4783376", "year": 1973, "title": "Comparative antioestrogenicity of cis & trans clomiphene citrate in rats during delayed implantation.", "journal": "Indian journal of experimental biology", "doi": null, "authors": [ "Sankaran MS", "Prasad MR" ], "first_affiliation": null, "model": "animal", "design": "rat antiestrogenicity", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": true, "note": "indexed to Enclomiphene by MeSH only", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/4783376/" }, { "pmid": "4810202", "year": 1974, "title": "Effect of cis-and trans-clomiphene on mammary gland development in the rat.", "journal": "Fertility and sterility", "doi": "10.1016/s0015-0282(16)40156-1", "authors": [ "Richards JF", "Griffith DR" ], "first_affiliation": null, "model": "animal", "design": "rat mammary gland", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": true, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/4810202/" }, { "pmid": "61699", "year": 1976, "title": "Effects of trans-clomiphene in combination with AY-9944 on rat CNS morphology and biochemistry.", "journal": "Acta neuropathologica", "doi": "10.1007/BF00685152", "authors": [ "Ramsey RB", "Fischer VW" ], "first_affiliation": null, "model": "animal", "design": "developing rat CNS", "role": "ZU", "origin": "IN", "country": "NR", "label_pre_1977": true, "note": "'trans-clomiphene' here = zuclomiphene: same group's 1977 paper (PMID 70952) states zuclomiphene was 'formerly called trans-clomiphene'", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/61699/" }, { "pmid": "992480", "year": 1976, "title": "Effects of Cis- and trans-clomiphene on the uterine blood flow of oophorectomized ewes.", "journal": "Gynecologic investigation", "doi": "10.1159/000301381", "authors": [ "Still JG", "Greiss FC" ], "first_affiliation": null, "model": "animal", "design": "ewe uterine blood flow", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": true, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/992480/" }, { "pmid": "70952", "year": 1977, "title": "Effects of zuclomiphene in combination with triparanol and ay-9944 on developing rat CNS morphology and biochemistry.", "journal": "Acta neuropathologica", "doi": "10.1007/BF00690391", "authors": [ "Ramsey RB", "Fischer VW" ], "first_affiliation": null, "model": "animal", "design": "developing rat CNS", "role": "ZU", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "zuclomiphene study; abstract documents the label reversal", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/70952/" }, { "pmid": "908269", "year": 1977, "title": "Anti-estrogenic compounds increase prolactin and growth hormone synthesis in clonal strains of rat pituitary cells.", "journal": "Endocrinology", "doi": "10.1210/endo-101-4-1151", "authors": [ "Dannies PS", "Yen PM", "Tashijian AH" ], "first_affiliation": null, "model": "in_vitro", "design": "rat pituitary cell lines", "role": "E", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "enclomiphene as one of several antiestrogens", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/908269/" }, { "pmid": "620073", "year": 1978, "title": "Estrogen-induced synthesis of riboflavin-binding protein in immature chicks. Kinetics and hormonal specificity.", "journal": "Biochimica et biophysica acta", "doi": "10.1016/0304-4165(78)90364-1", "authors": [ "Murthy US", "Adiga PR" ], "first_affiliation": null, "model": "animal", "design": "immature chick", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "cis and trans clomiphene as antiestrogen tools", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/620073/" }, { "pmid": "16725484", "year": 1980, "title": "Induction of estrus in anestrous cows treated with 'Fertivet'.", "journal": "Theriogenology", "doi": "10.1016/0093-691x(80)90121-1", "authors": [ "Dugwekar YG", "Pangawkar GR", "Sharma RD" ], "first_affiliation": "Department of Obstetrics and Gynaecology, Punjab Agricultural University, Ludhiana, India.", "model": "animal", "design": "anestrous cows (veterinary product)", "role": "MIX", "origin": "IN", "country": "India", "label_pre_1977": false, "note": "Fertivet = cis+trans mixture", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/16725484/" }, { "pmid": "6248140", "year": 1980, "title": "Direct inhibitory effect of enclomiphene citrate and estradiol on testis functions in hypophysectomized rats.", "journal": "Biology of reproduction", "doi": "10.1093/biolreprod/22.3.645", "authors": [ "Wang C", "Erickson GF", "Hopper B", "Bsueh AJ" ], "first_affiliation": null, "model": "animal", "design": "hypophysectomised rat testis", "role": "E", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "no abstract", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/6248140/" }, { "pmid": "6117445", "year": 1981, "title": "Rabbit liver microsomal metabolism of enclomiphene.", "journal": "Drug metabolism and disposition: the biological fate of chemicals", "doi": null, "authors": [ "Ruenitz PC" ], "first_affiliation": null, "model": "in_vitro", "design": "rabbit liver microsomes", "role": "E", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "metabolism", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/6117445/" }, { "pmid": "6456040", "year": 1981, "title": "[Influence of synthetic estrogens on experimental Schistosoma mansoni parasitosis in hamsters: cis and trans clomiphene isomers].", "journal": "Comptes rendus des seances de la Societe de biologie et de ses filiales", "doi": null, "authors": [ "Barrabes A", "Duong TH", "Combescot C", "Lacroix R" ], "first_affiliation": null, "model": "animal", "design": "hamster schistosomiasis", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "French; MeSH only", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/6456040/" }, { "pmid": "6781360", "year": 1981, "title": "Disparate effect of clomiphene and tamoxifen on pituitary gonadotropin release in vitro.", "journal": "The American journal of physiology", "doi": "10.1152/ajpendo.1981.240.2.E125", "authors": [ "Adashi EY", "Hsueh AJ", "Bambino TH", "Yen SS" ], "first_affiliation": null, "model": "in_vitro", "design": "rat pituitary cells", "role": "E", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "Clomid vs Enclomid vs tamoxifen; adjudicated from ISO after double coding", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/6781360/" }, { "pmid": "6781873", "year": 1981, "title": "Geometric isomers of substituted triphenylethylenes and antiestrogen action.", "journal": "Endocrinology", "doi": "10.1210/endo-108-4-1353", "authors": [ "Jordan VC", "Haldemann B", "Allen KE" ], "first_affiliation": null, "model": "animal", "design": "immature rat uterotrophic", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/6781873/" }, { "pmid": "6783716", "year": 1981, "title": "Agonist and antagonist activity of en-clomiphene upon oestrogen-mediated events in the uterus, pituitary gland and brain of the rat.", "journal": "The Journal of endocrinology", "doi": "10.1677/joe.0.0880367", "authors": [ "Bowman SP", "Leake A", "Miller M", "Morris ID" ], "first_affiliation": null, "model": "animal", "design": "ovariectomised rat", "role": "E", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/6783716/" }, { "pmid": "6783718", "year": 1981, "title": "Time-related effects of en-clomiphene upon central and peripheral oestrogen target tissues and cytoplasmic receptors.", "journal": "The Journal of endocrinology", "doi": "10.1677/joe.0.0890117", "authors": [ "Bowman SP", "Leake A", "Morris ID" ], "first_affiliation": null, "model": "animal", "design": "ovariectomised rat", "role": "E", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/6783718/" }, { "pmid": "6215092", "year": 1982, "title": "[Effect of the administration of estrogen-antiestrogen combinations on the experimental infection of the hamster with Schistosoma mansoni].", "journal": "Comptes rendus des seances de la Societe de biologie et de ses filiales", "doi": null, "authors": [ "Barrabes A", "Duong TH", "Lacroix R", "Combescot C" ], "first_affiliation": null, "model": "animal", "design": "hamster schistosomiasis", "role": "E", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "French; trans-clomifene with estrogens", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/6215092/" }, { "pmid": "6950028", "year": 1982, "title": "Subcellular distribution of 3 alpha-hydroxysteroid dehydrogenase and antiestrogen action on androgen-metabolizing enzymes in rat pituitary gland.", "journal": "Journal of neurochemistry", "doi": "10.1111/j.1471-4159.1982.tb05324.x", "authors": [ "Ghraf R", "Schneider K", "Kirchhoff J", "Hiemke C" ], "first_affiliation": null, "model": "animal", "design": "castrated rat pituitary", "role": "E", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "enclomiphene among antiestrogens", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/6950028/" }, { "pmid": "7118895", "year": 1982, "title": "The inhibition of the estrogen receptor's positive cooperative [3H]estradiol binding by the antagonist, clomiphene.", "journal": "The Journal of biological chemistry", "doi": null, "authors": [ "Sasson S", "Notides AC" ], "first_affiliation": null, "model": "in_vitro", "design": "calf uterine receptor binding", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/7118895/" }, { "pmid": "7148904", "year": 1982, "title": "A specific cytosolic estrogen receptor in human term placenta.", "journal": "American journal of obstetrics and gynecology", "doi": "10.1016/0002-9378(82)90356-8", "authors": [ "Kneussl ES", "Ances IG", "Albrecht ED" ], "first_affiliation": null, "model": "in_vitro", "design": "human placental cytosol", "role": "E", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "enclomiphene as competitor ligand", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/7148904/" }, { "pmid": "6401242", "year": 1983, "title": "Estrogenic and antiestrogenic effects of enclomiphene and zuclomiphene on gonadotropin secretion by ovine pituitary cells in culture.", "journal": "Endocrinology", "doi": "10.1210/endo-112-2-442", "authors": [ "Huang ES", "Miller WL" ], "first_affiliation": null, "model": "in_vitro", "design": "ovine pituitary cells", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/6401242/" }, { "pmid": "6406767", "year": 1983, "title": "The estrogenic effects of clomiphene during the neonatal period in the rat.", "journal": "Journal of steroid biochemistry", "doi": "10.1016/0022-4731(83)90124-3", "authors": [ "Clark JH", "Guthrie SC" ], "first_affiliation": null, "model": "animal", "design": "neonatal rat", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/6406767/" }, { "pmid": "6408114", "year": 1983, "title": "Antitumor activity of clomiphene analogs in vitro: relationship to affinity for the estrogen receptor and another high affinity antiestrogen-binding site.", "journal": "The Journal of clinical endocrinology and metabolism", "doi": "10.1210/jcem-57-2-373", "authors": [ "Murphy LC", "Sutherland RL" ], "first_affiliation": null, "model": "in_vitro", "design": "MCF-7 cells", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "enclomiphene analogues + zuclomiphene", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/6408114/" }, { "pmid": "6409349", "year": 1983, "title": "Long-term priming with a low dosage of estradiol benzoate or an antiestrogen (enclomiphene) increases nuclear progestin receptor levels in brain.", "journal": "Brain research", "doi": "10.1016/0006-8993(83)90655-8", "authors": [ "Wilcox JN", "Feder HH" ], "first_affiliation": null, "model": "animal", "design": "rat brain receptors", "role": "E", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "no abstract", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/6409349/" }, { "pmid": "6661654", "year": 1983, "title": "Estrogen agonistic and antagonistic action of 8 non-steroidal antiestrogens on progestin receptor induction in rat pituitary gland and uterus.", "journal": "Brain research", "doi": "10.1016/0006-8993(83)90047-1", "authors": [ "Kirchhoff J", "Grünke W", "Hoffmann B", "Nagel W", "Ghraf R" ], "first_affiliation": null, "model": "animal", "design": "ovariectomised rat", "role": "E", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "8 antiestrogens", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/6661654/" }, { "pmid": "6098784", "year": 1984, "title": "Interaction of non-steroidal antiestrogens with dopamine receptor binding.", "journal": "Journal of steroid biochemistry", "doi": "10.1016/0022-4731(84)90028-1", "authors": [ "Hiemke C", "Ghraf R" ], "first_affiliation": null, "model": "in_vitro", "design": "rat brain dopamine receptor binding", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/6098784/" }, { "pmid": "6421335", "year": 1984, "title": "Gap junction modulation in rat uterus. II. Effects of antiestrogens on myometrial and serosal cells.", "journal": "Biology of reproduction", "doi": "10.1095/biolreprod30.1.249", "authors": [ "Burghardt RC", "Mitchell PA", "Kurten R" ], "first_affiliation": null, "model": "animal", "design": "hypophysectomised rat uterus", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/6421335/" }, { "pmid": "6439216", "year": 1984, "title": "Inhibition of the estradiol-induced growth of cultured human breast cancer cells by the anti-estrogens tamoxifen, desmethyl-tamoxifen, 4-hydroxy-tamoxifen and enclomiphene.", "journal": "Biochemical pharmacology", "doi": "10.1016/0006-2952(84)90007-8", "authors": [ "Marth C", "Daxenbichler G", "Buehring GC", "Hofstädter F", "Dapunt O" ], "first_affiliation": null, "model": "in_vitro", "design": "human breast cancer cells", "role": "E", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/6439216/" }, { "pmid": "2411529", "year": 1985, "title": "Changes in keratin expression during the estrogen-mediated differentiation of rat vaginal epithelium.", "journal": "Endocrinology", "doi": "10.1210/endo-117-4-1480", "authors": [ "Kronenberg MS", "Clark JH" ], "first_affiliation": null, "model": "animal", "design": "rat vaginal epithelium", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/2411529/" }, { "pmid": "4009597", "year": 1985, "title": "Ellipticine derivatives with an affinity to the estrogen receptor, an approach to develop intercalating drugs with a specific effect on the hormone-dependent breast cancer.", "journal": "Journal of medicinal chemistry", "doi": "10.1021/jm00383a011", "authors": [ "Delbarre A", "Oberlin R", "Roques BP", "Borgna JL", "Rochefort H", "Le Pecq JB", "Jacquemin-Sablon A" ], "first_affiliation": null, "model": "chem_analytical", "design": "synthesis of ellipticine conjugates", "role": "OTHER", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "(E)-clomiphene as vector", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/4009597/" }, { "pmid": "3083679", "year": 1986, "title": "The effects of enclomiphene and zuclomiphene citrates on mouse embryos fertilized in vitro and in vivo.", "journal": "American journal of obstetrics and gynecology", "doi": "10.1016/0002-9378(86)90444-8", "authors": [ "Schmidt GE", "Kim MH", "Mansour R", "Torello L", "Friedman CI" ], "first_affiliation": null, "model": "in_vitro", "design": "mouse embryos in culture", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/3083679/" }, { "pmid": "3112086", "year": 1987, "title": "Postpartum interval in beef cows shortened by enclomiphene.", "journal": "Journal of animal science", "doi": "10.2527/jas1987.651217x", "authors": [ "Chang CF", "Reeves JJ" ], "first_affiliation": null, "model": "animal", "design": "postpartum beef cows", "role": "E", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "veterinary", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/3112086/" }, { "pmid": "3117835", "year": 1987, "title": "Effect of clomiphene isomers on progestin synthesis in cultured human granulosa cells.", "journal": "Human reproduction (Oxford, England)", "doi": "10.1093/oxfordjournals.humrep.a136571", "authors": [ "Olsson JH", "Nilsson L", "Hillensjö T" ], "first_affiliation": "Department of Obstetrics and Gynaecology, University of Göteborg, Sweden.", "model": "in_vitro", "design": "human granulosa cells", "role": "ISO", "origin": "IN", "country": "Sweden", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/3117835/" }, { "pmid": "3586657", "year": 1987, "title": "Triphenylethylene antiestrogen binding sites (TABS) specificity.", "journal": "Journal of steroid biochemistry", "doi": "10.1016/0022-4731(87)90052-5", "authors": [ "Clark JH", "Mitchell WC", "Guthrie SC" ], "first_affiliation": null, "model": "in_vitro", "design": "rat liver binding sites", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/3586657/" }, { "pmid": "3593845", "year": 1987, "title": "Gap junction modulation in rat uterus. III. Structure-activity relationships of estrogen receptor-binding ligands on myometrial and serosal cells.", "journal": "Biology of reproduction", "doi": "10.1095/biolreprod36.3.741", "authors": [ "Burghardt RC", "Gaddy-Kurten D", "Burghardt RL", "Kurten RC", "Mitchell PA" ], "first_affiliation": null, "model": "animal", "design": "hypophysectomised rat uterus", "role": "ISO", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/3593845/" }, { "pmid": "3131115", "year": 1988, "title": "Differential responses of sex steroid target tissues of rats treated with 4-hydroxyandrostenedione.", "journal": "Endocrinology", "doi": "10.1210/endo-122-6-2418", "authors": [ "Wing LY", "Hammond JO", "Brodie AM" ], "first_affiliation": "Department of Pharmacology and Experimental Therapeutics, University of Maryland School of Medicine, Baltimore 21201.", "model": "animal", "design": "rat aromatase-inhibitor model", "role": "E", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/3131115/" }, { "pmid": "3139938", "year": 1988, "title": "Binding and biologic activity of diethylstilbestrol in the hamster: influence of a serum component on estrogen receptor binding and estrogenic activity.", "journal": "Journal of steroid biochemistry", "doi": "10.1016/0022-4731(88)90304-4", "authors": [ "Okulicz WC", "Leavitt WW" ], "first_affiliation": "Department of Obstetrics/Gynecology, UMASS Medical School, Worcester, MA 01655.", "model": "animal", "design": "hamster uterus/receptor binding", "role": "E", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "enclomiphene as comparator ligand", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/3139938/" }, { "pmid": "3192066", "year": 1988, "title": "A plasma steroid hormone binding protein in the viviparous water snake, Nerodia.", "journal": "General and comparative endocrinology", "doi": "10.1016/0016-6480(88)90271-7", "authors": [ "Riley D", "Kleis-San Francisco SM", "Callard IP" ], "first_affiliation": "Boston University, Department of Biology, Massachusetts 02215.", "model": "in_vitro", "design": "water snake plasma binding protein", "role": "ISO", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/3192066/" }, { "pmid": "2492231", "year": 1989, "title": "Enclomiphene induces luteolysis in the nonpregnant guinea pig.", "journal": "Experientia", "doi": "10.1007/BF01990463", "authors": [ "Westfahl PK" ], "first_affiliation": "Department of Zoology, Miami University, Oxford, Ohio 45056.", "model": "animal", "design": "guinea pig luteolysis", "role": "E", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/2492231/" }, { "pmid": "2497133", "year": 1989, "title": "A comparison of the effects on follicular development between clomiphene citrate, its two separate isomers and spontaneous cycles.", "journal": "Human reproduction (Oxford, England)", "doi": "10.1093/oxfordjournals.humrep.a136882", "authors": [ "Glasier AF", "Irvine DS", "Wickings EJ", "Hillier SG", "Baird DT" ], "first_affiliation": "Department of Obstetrics and Gynaecology, University of Edinburgh, UK.", "model": "human", "design": "crossover-type cycles in women", "role": "ISO", "origin": "IN", "country": "UK", "label_pre_1977": false, "note": "19 women; clomiphene cycle then En or Zu alone; only En and CC increased follicles", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/2497133/" }, { "pmid": "2600898", "year": 1989, "title": "Modulation of intrafollicular oestradiol in explanted hamster follicles does not affect oocyte meiotic status.", "journal": "Journal of reproduction and fertility", "doi": "10.1530/jrf.0.0870409", "authors": [ "Racowsky C", "Baldwin KV" ], "first_affiliation": "Department of Zoology, Arizona State University, Tempe 85287-1501.", "model": "in_vitro", "design": "explanted hamster follicles", "role": "E", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/2600898/" }, { "pmid": "2081804", "year": 1990, "title": "Effect of clomiphene isomers on oestradiol synthesis in cultured human granulosa cells.", "journal": "Human reproduction (Oxford, England)", "doi": "10.1093/oxfordjournals.humrep.a137222", "authors": [ "Olsson JH", "Granberg S" ], "first_affiliation": "Department of Obstetrics and Gynaecology, University of Göteborg, Sweden.", "model": "in_vitro", "design": "human granulosa cells", "role": "ISO", "origin": "IN", "country": "Sweden", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/2081804/" }, { "pmid": "2123847", "year": 1990, "title": "Effects of enclomiphene on estradiol-induced changes in LH secretion in ewes.", "journal": "Journal of animal science", "doi": "10.2527/1990.68103293x", "authors": [ "Gregg DW", "Nett TM" ], "first_affiliation": "Dept. of Physiol., Colorado State University, Fort Collins 80523.", "model": "animal", "design": "ovariectomised ewes", "role": "E", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/2123847/" }, { "pmid": "2334915", "year": 1990, "title": "Effect of steroidal and nonsteroidal antiestrogens on the growth of a tamoxifen-stimulated human endometrial carcinoma (EnCa101) in athymic mice.", "journal": "Cancer research", "doi": null, "authors": [ "Gottardis MM", "Ricchio ME", "Satyaswaroop PG", "Jordan VC" ], "first_affiliation": "Department of Human Oncology, University of Wisconsin Clinical Cancer Center, Madison.", "model": "animal", "design": "athymic mice tumour xenograft", "role": "E", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/2334915/" }, { "pmid": "1778825", "year": 1991, "title": "Enclomiphene does not alter the postpartum interval of suckled beef cows.", "journal": "Journal of animal science", "doi": "10.2527/1991.69104112x", "authors": [ "Schramm RD", "Roberge S", "Reeves JJ" ], "first_affiliation": "Dept. of Anim. Sci., Washington State University, Pullman 99164-6332.", "model": "animal", "design": "postpartum beef cows", "role": "E", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "null result", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/1778825/" }, { "pmid": "1905895", "year": 1991, "title": "Tamoxifen-stimulated growth of human endometrial carcinoma.", "journal": "Annals of the New York Academy of Sciences", "doi": "10.1111/j.1749-6632.1991.tb37886.x", "authors": [ "Jordan VC", "Gottardis MM", "Satyaswaroop PG" ], "first_affiliation": "Department of Human Oncology, University of Wisconsin, Madison 53792.", "model": "animal", "design": "athymic mice tumour xenograft", "role": "E", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/1905895/" }, { "pmid": "1906682", "year": 1991, "title": "Effect of clomiphene citrate treatment on endometrial estrogen and progesterone receptor induction in women.", "journal": "American journal of obstetrics and gynecology", "doi": "10.1016/0002-9378(91)90247-o", "authors": [ "Fritz MA", "Holmes RT", "Keenan EJ" ], "first_affiliation": "Department of Obstetrics and Gynecology, United States Air Force Medical Center Wright-Patterson, Ohio.", "model": "human", "design": "clomiphene cycles, endometrium", "role": "MIX", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "5 women; 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zuclomiphene accumulates across cycles", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/10202872/" }, { "pmid": "10465261", "year": 1999, "title": "Effect of estrogen agonists and antagonists on induction of progesterone receptor in a rat hypothalamic cell line.", "journal": "Endocrinology", "doi": "10.1210/endo.140.9.7006", "authors": [ "Fitzpatrick SL", "Berrodin TJ", "Jenkins SF", "Sindoni DM", "Deecher DC", "Frail DE" ], "first_affiliation": "Women's Health Research Institute, Wyeth-Ayerst Research, Radnor, Pennsylvania 19087, USA. fitzpas2@war.wyeth.com", "model": "in_vitro", "design": "rat hypothalamic cell line", "role": "ISO", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "industry lab (Wyeth), not sponsor", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/10465261/" }, { "pmid": "10489529", "year": 1999, "title": "Characterization of minor site probes for human serum albumin by high-performance affinity chromatography.", "journal": "Analytical chemistry", "doi": "10.1021/ac9903499", "authors": [ "Sengupta A", "Hage DS" ], "first_affiliation": "Chemistry Department, University of Nebraska, Lincoln 68588-0304, USA.", "model": "chem_analytical", "design": "albumin binding-site probes", "role": "ISO", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/10489529/" }, { "pmid": "11156570", "year": 2001, "title": "Inhibition of volume-regulated anion channels in cultured endothelial cells by the anti-oestrogens clomiphene and nafoxidine.", "journal": "British journal of pharmacology", "doi": "10.1038/sj.bjp.0703786", "authors": [ "Maertens C", "Droogmans G", "Chakraborty P", "Nilius B" ], "first_affiliation": "KU Leuven, Laboratorium voor Fysiologie, Campus Gasthuisberg, B-3000 LEUVEN, Belgium.", "model": "in_vitro", "design": "endothelial cells patch clamp", "role": "ISO", "origin": "IN", "country": "Belgium", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/11156570/" }, { "pmid": "11399474", "year": 2001, "title": "Regulation of plasma gonadotropin II secretion by sex steroids, aromatase inhibitors, and antiestrogens in the protandrous black porgy, Acanthopagrus schlegeli Bleeker.", "journal": "Comparative biochemistry and physiology. 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Hallamshire Hospital, Sheffield, S10 2JF, UK.", "model": "human", "design": "single-dose PK, women with PCOS", "role": "MIX", "origin": "IN", "country": "UK", "label_pre_1977": false, "note": "9 patients", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/19033451/" }, { "pmid": "19046677", "year": 2009, "title": "A method by homemade OH/TSO-PMHS fibre solid-phase microextraction coupling with gas chromatography-mass spectrometry for analysis of antiestrogens in biological matrices.", "journal": "Analytica chimica acta", "doi": "10.1016/j.aca.2008.10.012", "authors": [ "Liu W", "Zhang L", "Chen S", "Duan H", "Chen X", "Wei Z", "Chen G" ], "first_affiliation": "Ministry of Education Key Laboratory of Analysis and Detection for Food Safety (Fuzhou University), Analytical and Testing Center, The Sport Science Research Center, Fuzhou University, Fuzhou, Fujian 350002, China.", "model": "chem_analytical", "design": "SPME GC-MS method", "role": "ISO", "origin": "IN", "country": "China", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/19046677/" }, { "pmid": "19204885", "year": 2009, "title": "Enclomiphene, an estrogen receptor antagonist for the treatment of testosterone deficiency in men.", "journal": "IDrugs : the investigational drugs journal", "doi": null, "authors": [ "Hill S", "Arutchelvam V", "Quinton R" ], "first_affiliation": "Department of Clinical Pharmacology & Therapeutics, Royal Victoria Infirmary, Queen Victoria Road, Newcastle upon Tyne, NE1 4LP, UK.", "model": "review", "design": "drug profile review", "role": "SEC", "origin": "IN", "country": "UK", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/19204885/" }, { "pmid": "19938905", "year": 2009, "title": "Clomiphene citrate and enclomiphene for the treatment of hypogonadal androgen deficiency.", "journal": "Expert opinion on investigational drugs", "doi": "10.1517/13543780903405608", "authors": [ "Kaminetsky J", "Hemani ML" ], "first_affiliation": "NYU Langone Medical Center - Department of Urology, New York, New York 10016, USA. jckammd@att.net", "model": "review", "design": "narrative review", "role": "SEC", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "first author later a programme investigator", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/19938905/" }, { "pmid": "23530575", "year": 2013, "title": "Oral enclomiphene citrate stimulates the endogenous production of testosterone and sperm counts in men with low testosterone: comparison with testosterone gel.", "journal": "The journal of sexual medicine", "doi": "10.1111/jsm.12116", "authors": [ "Kaminetsky J", "Werner M", "Fontenot G", "Wiehle RD" ], "first_affiliation": "University Urology Associates, New York, NY, USA.", "model": "human", "design": "randomised open-label phase 2b vs testosterone gel", "role": "E", "origin": "SP", "country": "USA", "label_pre_1977": false, "note": "12 men; Repros co-authors", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/23530575/" }, { "pmid": "23875626", "year": 2013, "title": "Testosterone Restoration by Enclomiphene Citrate in Men with Secondary Hypogonadism: Pharmacodynamics and Pharmacokinetics.", "journal": "BJU international", "doi": "10.1111/bju.12363", "authors": [ "Wiehle R", "Cunningham GR", "Pitteloud N", "Wike J", "Hsu K", "Fontenot GK", "Rosner M", "Dwyer A", "Podolski J" ], "first_affiliation": "Repros Therapeutics Inc, Houston, TX.", "model": "human", "design": "randomised phase 2, PK/PD vs testosterone gel", "role": "E", "origin": "SP", "country": "USA", "label_pre_1977": false, "note": "48 men; Repros authors", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/23875626/" }, { "pmid": "25044078", "year": 2014, "title": "Selective estrogen receptor modulators, male hypogonadism, and infertility.", "journal": "Fertility and sterility", "doi": "10.1016/j.fertnstert.2014.06.029", "authors": [ "Ross LS" ], "first_affiliation": "Department of Urology, University of Illinois, Chicago, Illinois.", "model": "commentary", "design": "editorial comment", "role": "SEC", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "MeSH only", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/25044078/" }, { "pmid": "25044085", "year": 2014, "title": "Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone.", "journal": "Fertility and sterility", "doi": "10.1016/j.fertnstert.2014.06.004", "authors": [ "Wiehle RD", "Fontenot GK", "Wike J", "Hsu K", "Nydell J", "Lipshultz L", "ZA-203 Clinical Study Group" ], "first_affiliation": "Department of Urology, Repros Therapeutics Inc., Houston, Texas. Electronic address: rwiehle@reprosrx.com.", "model": "human", "design": "randomised phase 2 (ZA-203, NCT01270841)", "role": "E", "origin": "SP", "country": "USA", "label_pre_1977": false, "note": "Repros authors", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/25044085/" }, { "pmid": "25986825", "year": 2015, "title": "Re: Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone.", "journal": "The Journal of urology", "doi": "10.1016/j.juro.2015.03.052", "authors": [ "Niederberger C" ], "first_affiliation": null, "model": "commentary", "design": "journal comment", "role": "SEC", "origin": "IN", "country": "NR", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/25986825/" }, { "pmid": "26220499", "year": 2016, "title": "Differential effects of isomers of clomiphene citrate on reproductive tissues in male mice.", "journal": "BJU international", "doi": "10.1111/bju.13244", "authors": [ "Fontenot GK", "Wiehle RD", "Podolski JS" ], "first_affiliation": "Repros Therapeutics Inc., The Woodlands, TX, USA.", "model": "animal", "design": "chronic oral toxicity, male mice", "role": "ISO", "origin": "SP", "country": "USA", "label_pre_1977": false, "note": "Repros authors", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/26220499/" }, { "pmid": "26496621", "year": 2016, "title": "Oral enclomiphene citrate raises testosterone and preserves sperm counts in obese hypogonadal men, unlike topical testosterone: restoration instead of replacement.", "journal": "BJU international", "doi": "10.1111/bju.13337", "authors": [ "Kim ED", "McCullough A", "Kaminetsky J" ], "first_affiliation": "University of Tennessee Graduate School of Medicine, Knoxville, TN, USA.", "model": "human", "design": "two randomised phase 3 (ZA-304/ZA-305), pooled", "role": "E", "origin": "SD", "country": "USA", "label_pre_1977": false, "note": "sponsor trial data", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/26496621/" }, { "pmid": "26787395", "year": 2016, "title": "Reproductive endocrinology: Oral enclomiphene citrate in obese men with hypogonadism.", "journal": "Nature reviews. Urology", "doi": "10.1038/nrurol.2015.311", "authors": [ "Kovac JR" ], "first_affiliation": "Men's Health Center, Urology of Indiana, 8240 Naab Road, Suite 200, Indianapolis, Indiana 46260, USA.", "model": "commentary", "design": "research highlight", "role": "SEC", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/26787395/" }, { "pmid": "26839488", "year": 2016, "title": "Genetic Polymorphism of CYP2D6 and Clomiphene Concentrations in Infertile Patients with Ovulatory Dysfunction Treated with Clomiphene Citrate.", "journal": "Journal of Korean medical science", "doi": "10.3346/jkms.2016.31.2.310", "authors": [ "Ji M", "Kim KR", "Lee W", "Choe W", "Chun S", "Min WK" ], "first_affiliation": "Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea.", "model": "human", "design": "cohort, CYP2D6 genotype", "role": "MIX", "origin": "IN", "country": "South Korea", "label_pre_1977": false, "note": "42 women", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/26839488/" }, { "pmid": "27337642", "year": 2016, "title": "Enclomiphene citrate for the treatment of secondary male hypogonadism.", "journal": "Expert opinion on pharmacotherapy", "doi": "10.1080/14656566.2016.1204294", "authors": [ "Rodriguez KM", "Pastuszak AW", "Lipshultz LI" ], "first_affiliation": "a Baylor College of Medicine , Houston , TX , USA.", "model": "review", "design": "narrative review", "role": "SEC", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/27337642/" }, { "pmid": "27490565", "year": 2016, "title": "Clomiphene and Its Isomers Block Ebola Virus Particle Entry and Infection with Similar Potency: Potential Therapeutic Implications.", "journal": "Viruses", "doi": "10.1111/j.1365-2125.1989.tb03430.x", "authors": [ "Nelson EA", "Barnes AB", "Wiehle RD", "Fontenot GK", "Hoenen T", "White JM" ], "first_affiliation": "Department of 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secondary hypogonadism.", "journal": "Expert review of endocrinology & metabolism", "doi": "10.1080/17446651.2019.1612239", "authors": [ "Earl JA", "Kim ED" ], "first_affiliation": "a Department of Urology , University of Tennessee, Graduate School of Medicine , Knoxville , TN , USA.", "model": "review", "design": "drug profile review", "role": "SEC", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "author group of the phase 3 publication", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/31063005/" }, { "pmid": "33003069", "year": 2020, "title": "Leydig stem cells and future therapies for hypogonadism.", "journal": "Current opinion in endocrinology, diabetes, and obesity", "doi": "10.1097/MED.0000000000000580", "authors": [ "Achua JK", "Frech FS", "Ramasamy R" ], "first_affiliation": "Department of Urology, University of Miami Miller School of Medicine, Miami, Florida, USA.", "model": "review", "design": "narrative review", "role": "SEC", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/33003069/" }, { "pmid": "35259334", "year": 2022, "title": "Are SERMs safe and effective for the treatment of hypogonadism in men?", "journal": "The Journal of family practice", "doi": "10.12788/jfp.0342", "authors": [ "Joseph T", "Gibbs LM", "Pham K" ], "first_affiliation": "Methodist Charlton Family Medicine Residency, Dallas, TX.", "model": "review", "design": "clinical inquiry", "role": "SEC", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/35259334/" }, { "pmid": "36559098", "year": 2022, "title": "Prediction of Drug-Drug-Gene Interaction Scenarios of (E)-Clomiphene and Its Metabolites Using Physiologically Based Pharmacokinetic Modeling.", "journal": "Pharmaceutics", "doi": "10.1023/A:1012299115260", "authors": [ "Kovar C", "Kovar L", "Rüdesheim S", "Selzer D", "Ganchev B", "Kröner P", "Igel S", "Kerb R", "Schaeffeler E", "Mürdter TE", "Schwab M", "Lehr T" ], "first_affiliation": "Clinical Pharmacy, Saarland University, 66123 Saarbrücken, Germany.", "model": "modelling", "design": "PBPK model of (E)-clomiphene", "role": "E", "origin": "IN", "country": "Germany", "label_pre_1977": false, "note": "in silico, built on published data", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/36559098/" }, { "pmid": "36604313", "year": 2023, "title": "Selective modulation of estrogen receptor in obese men with androgen deficiency: A systematic review and meta-analysis.", "journal": "Andrology", "doi": "10.1111/andr.13373", "authors": [ "Tienforti D", "Castellini C", "Di Giulio F", "Totaro M", "Dalmazio G", "Spagnolo L", "Muselli M", "Corona G", "Baroni MG", "Barbonetti A" ], "first_affiliation": "Department of Clinical Medicine, Life, Health and Environmental Sciences, Andrology Unit, University of L'Aquila, L'Aquila, Italy.", "model": "review", "design": "systematic review/meta-analysis", "role": "SEC", "origin": 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"https://pubmed.ncbi.nlm.nih.gov/41066380/" }, { "pmid": "41071236", "year": 2025, "title": "Comparison between Amorphous States of the Trans/Cis Isomers of Clomiphene: Similarities and Differences.", "journal": "Molecular pharmaceutics", "doi": "10.1021/acs.molpharmaceut.5c00888", "authors": [ "Trubert J", "Garda MR", "Matkovska L", "Gauthier S", "Lorieau B", "Gendron FX", "Coquerel G", "Couvrat N", "Delbreilh L", "Saiter-Fourcin A" ], "first_affiliation": "Univ Rouen Normandie, INSA Rouen Normandie, CNRS, Groupe de Physique des Matériaux UMR 6634, Rouen F-76000, France.", "model": "chem_analytical", "design": "amorphous-state physics of isomers", "role": "ISO", "origin": "IN", "country": "France", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/41071236/" }, { "pmid": "41312854", "year": 2025, "title": "Comment on Clomiphene or enclomiphene citrate for the treatment of male hypogonadism: a systematic review and meta-analysis of randomized 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of Enclomiphene in the Treatment of Male Hypogonadism.", "journal": "The world journal of men's health", "doi": "10.5534/wjmh.250395", "authors": [ "Foster J", "Choo L", "Patel A", "Kirby M", "Hackett G" ], "first_affiliation": "Croft Medical Centre, Warwickshire, UK.", "model": "commentary", "design": "society position statement", "role": "SEC", "origin": "IN", "country": "UK", "label_pre_1977": false, "note": "BSSM", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/41714894/" }, { "pmid": "42170362", "year": 2026, "title": "Changes in Serum Testosterone After Sublingual Enclomiphene Citrate Combined With a Mineral Oxide Delivery System: A Retrospective Case Series of 15 Men.", "journal": "Cureus", "doi": "10.7759/cureus.109299", "authors": [ "Warren S" ], "first_affiliation": "Regenerative Medicine, Regenerative Wellness Center, Salt Lake City, USA.", "model": "human", "design": "retrospective case series, compounded multi-ingredient product", "role": "COMBO", "origin": "IN", "country": "USA", "label_pre_1977": false, "note": "15 men", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/42170362/" }, { "pmid": "42387872", "year": 2026, "title": "Clomiphene Citrate in off-Label Post-Cycle Therapy: Mechanisms, Efficacy and Diagnostic Challenges in Endocrine Recovery Following Anabolic Steroid Use.", "journal": "Andrology", "doi": "10.1111/andr.70306", "authors": [ "Bandura A", "Furka S", "Hromníková D", "Kalafutová I", "Furka D", "Böhmer D" ], "first_affiliation": "Faculty of Medicine, Institute of Medical Biology, Genetics and Clinical Genetics, Comenius University, Bratislava, Slovakia.", "model": "review", "design": "narrative review (post-cycle therapy)", "role": "SEC", "origin": "IN", "country": "Slovakia", "label_pre_1977": false, "note": "", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/42387872/" }, { "pmid": "42741668", "year": 2026, "title": "Newly Detected Atrial Flutter After Enclomiphene Dose Escalation in a Patient With Prior Mitral Valve Repair and Chronic Immune Thrombocytopenia: A Case Report.", "journal": "Cureus", "doi": "10.7759/cureus.114562", "authors": [ "Tariq MN", "Abdel Halim AT", "Evans JA" ], "first_affiliation": "Medicine, Ayub Medical College, Abbottabad, PAK.", "model": "human", "design": "case report", "role": "E", "origin": "IN", "country": "Pakistan", "label_pre_1977": false, "note": "atrial flutter", "pubmed_url": "https://pubmed.ncbi.nlm.nih.gov/42741668/" } ], "trials": [ { "nct": "NCT00706719", "code": "ZA-201", "sponsor": "Repros Therapeutics Inc.", "category": "efficacy", "phase": "2", "allocation": "RANDOMIZED", "masking": "NONE", "enrolment": 17, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2008-06", "completion": "2009-08", "results_posted": true, "results_first_posted": "2010-10-08", "primary_endpoint": "Sperm concentration and motility after switching from a testosterone product", "primary_result": "Sperm concentration higher than testosterone-comparator arm at month 3 (posted 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"QUADRUPLE", "enrolment": 83, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2011-01", "completion": "2011-12", "results_posted": true, "results_first_posted": "2014-07-28", "primary_endpoint": "Change in morning total testosterone at 3 months vs placebo and testosterone comparator", "primary_result": "Testosterone rose vs placebo; similar to testosterone comparator", "result_source": "CT.gov + PubMed", "pubmed": "25044085", "pubmed_certainty": "identifier", "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT01270841" }, { "nct": "NCT01386606", "code": "ZA-204", "sponsor": "Repros Therapeutics Inc.", "category": "efficacy", "phase": "2", "allocation": "RANDOMIZED", "masking": "SINGLE", "enrolment": 60, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2011-06", "completion": "2011-10", "results_posted": true, "results_first_posted": "2015-09-23", "primary_endpoint": "24-h average and peak testosterone at 6 weeks vs testosterone comparator", "primary_result": "Testosterone rose in all arms; not different from comparator (article p = 0.23); dose-response regression posted", "result_source": "CT.gov + PubMed", "pubmed": "23875626", "pubmed_certainty": "design and arm sizes", "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT01386606" }, { "nct": "NCT01532414", "code": "ZA-301", "sponsor": "Repros Therapeutics Inc.", "category": "efficacy", "phase": "3", "allocation": "RANDOMIZED", "masking": "DOUBLE", "enrolment": 151, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2012-08", "completion": "2013-03", "results_posted": true, "results_first_posted": "2015-05-27", "primary_endpoint": "Co-primary: share of men with testosterone in range; non-inferiority to placebo on >=50% sperm drop", "primary_result": "Testosterone endpoint met (78.8%); sperm non-inferiority met in the ITT population, not in the per-protocol population (EPAR)", "result_source": "CT.gov + EPAR", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT01532414" }, { "nct": "NCT01739595", "code": "ZA-302", "sponsor": "Repros Therapeutics Inc.", "category": "efficacy", "phase": "3", "allocation": "RANDOMIZED", "masking": "DOUBLE", "enrolment": 181, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2012-11", "completion": "2013-09", "results_posted": true, "results_first_posted": "2015-05-27", "primary_endpoint": "Co-primary: share in testosterone range; change in sperm concentration vs placebo", "primary_result": "Testosterone endpoint met (81.3%); sperm non-inferiority met in the ITT population, not in the per-protocol population (EPAR)", "result_source": "CT.gov + EPAR", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT01739595" }, { "nct": "NCT01993212", "code": "ZA-304", "sponsor": "Repros Therapeutics Inc.", "category": "efficacy", "phase": "3", "allocation": "RANDOMIZED", "masking": "DOUBLE", "enrolment": 120, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2014-01", "completion": "2014-09", "results_posted": false, "results_first_posted": null, "primary_endpoint": "Composite: testosterone in range AND sperm >=10 million/mL at 16 weeks vs testosterone comparator and placebo", "primary_result": "Met: 25/41 (61.0%) vs 7/43 (16.3%) testosterone comparator and 2/45 (4.4%) placebo (EPAR Table 34)", "result_source": "EPAR + PubMed", "pubmed": "26496621", "pubmed_certainty": "identifier", "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT01993212" }, { "nct": "NCT01993225", "code": "ZA-305", "sponsor": "Repros Therapeutics Inc.", "category": "efficacy", "phase": "3", "allocation": "RANDOMIZED", "masking": "DOUBLE", "enrolment": 120, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2014-01", "completion": "2014-08", "results_posted": false, "results_first_posted": null, "primary_endpoint": "Same composite as ZA-304", "primary_result": "Met: 29/44 (65.9%) vs 14/42 (33.3%) testosterone comparator and 3/41 (7.3%) placebo. Comparator value from the EPAR discussion; EPAR Table 39 prints 7 (16.3%), but that column does not sum to its N and only 14/42 reproduces the table's own p-values (0.0025 chi-square, 0.0047 Fisher)", "result_source": "EPAR + PubMed", "pubmed": "26496621", "pubmed_certainty": "identifier", "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT01993225" }, { "nct": "NCT02160704", "code": "H-33673", "sponsor": "Baylor College of Medicine", "category": "efficacy", "phase": "2/3", "allocation": "RANDOMIZED", "masking": "DOUBLE", "enrolment": 0, "enrolment_type": "ACTUAL", "status": "WITHDRAWN", "start": "2014-09-22", "completion": "2016-08-02", "results_posted": false, "results_first_posted": null, "primary_endpoint": "Doubling of total motile sperm count (male infertility)", "primary_result": "Withdrawn before enrolment", "result_source": "n/a", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": false, "url": "https://clinicaltrials.gov/study/NCT02160704" }, { "nct": "NCT02651688", "code": "ZA-205", "sponsor": "Repros Therapeutics Inc.", "category": "efficacy", "phase": "2", "allocation": "RANDOMIZED", "masking": "QUADRUPLE", "enrolment": 50, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2016-01-11", "completion": "2017-05-02", "results_posted": true, "results_first_posted": "2019-06-14", "primary_endpoint": "Lean body mass and strength at 48 weeks vs placebo (obese men)", "primary_result": "Not met: no difference vs placebo in lean mass or strength (posted p 0.45 to 0.93); testosterone rose (p<0.01)", "result_source": "CT.gov", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT02651688" }, { "nct": "NCT01923857", "code": "ZA-104", "sponsor": "Repros Therapeutics Inc.", "category": "pk", "phase": "1", "allocation": "NON_RANDOMIZED", "masking": "NONE", "enrolment": 26, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2013-08", "completion": "2014-08", "results_posted": false, "results_first_posted": null, "primary_endpoint": "Pharmacokinetics in renal impairment", "primary_result": "Summarised in EPAR only", "result_source": "EPAR", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT01923857" }, { "nct": "NCT01923870", "code": "ZA-105", "sponsor": "Repros Therapeutics Inc.", "category": "pk", "phase": "1", "allocation": "NON_RANDOMIZED", "masking": "NONE", "enrolment": 19, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2013-08", "completion": "2014-01", "results_posted": false, "results_first_posted": null, "primary_endpoint": "Pharmacokinetics in hepatic impairment", "primary_result": "Summarised in EPAR only", "result_source": "EPAR", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT01923870" }, { "nct": "NCT01959685", "code": "ZA-109", "sponsor": "Repros Therapeutics Inc.", "category": "pk", "phase": "1", "allocation": "NA", "masking": "NONE", "enrolment": 9, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2013-10", "completion": "2013-11", "results_posted": true, "results_first_posted": "2014-08-11", "primary_endpoint": "Single-dose tolerability and pharmacokinetics", "primary_result": "PK values posted", "result_source": "CT.gov", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": false, "url": "https://clinicaltrials.gov/study/NCT01959685" }, { "nct": "NCT01984398", "code": "ZA-110", "sponsor": "Repros Therapeutics Inc.", "category": "pk", "phase": "1", "allocation": "RANDOMIZED", "masking": "QUADRUPLE", "enrolment": 16, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2013-12-31", "completion": "2013-12-31", "results_posted": true, "results_first_posted": "2019-05-06", "primary_endpoint": "Bioequivalence of two formulations", "primary_result": "Cmax values posted", "result_source": "CT.gov", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": false, "url": "https://clinicaltrials.gov/study/NCT01984398" }, { "nct": "NCT01991327", "code": "ZA-106", "sponsor": "Repros Therapeutics Inc.", "category": "pk", "phase": "1", "allocation": "NON_RANDOMIZED", "masking": "NONE", "enrolment": 30, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2014-05", "completion": "2014-07", "results_posted": false, "results_first_posted": null, "primary_endpoint": "Drug-drug interaction with CYP450 probes", "primary_result": "Summarised in EPAR only", "result_source": "EPAR", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT01991327" }, { "nct": "NCT02146391", "code": "ZA-107", "sponsor": "Repros Therapeutics Inc.", "category": "pk", "phase": "1", "allocation": null, "masking": "NONE", "enrolment": 12, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2014-06", "completion": "2014-07", "results_posted": false, "results_first_posted": null, "primary_endpoint": "Food effect on pharmacokinetics", "primary_result": "Food-effect study; exposure differed between conditions and fell outside bioequivalence limits (EPAR)", "result_source": "EPAR", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT02146391" }, { "nct": "NCT02169804", "code": "ZA-111", "sponsor": "Repros Therapeutics Inc.", "category": "pk", "phase": "1", "allocation": "NON_RANDOMIZED", "masking": "NONE", "enrolment": 24, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2014-08", "completion": "2014-08", "results_posted": false, "results_first_posted": null, "primary_endpoint": "Effect of age on pharmacokinetics", "primary_result": "Summarised in EPAR only", "result_source": "EPAR", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT02169804" }, { "nct": "NCT02274181", "code": "ZA-112", "sponsor": "Repros Therapeutics Inc.", "category": "pk", "phase": "1", "allocation": "NA", "masking": "NONE", "enrolment": 6, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2014-12", "completion": "2015-01", "results_posted": false, "results_first_posted": null, "primary_endpoint": "Mass balance / excretion", "primary_result": "~71% of radioactivity recovered in 7 days; metabolite characterisation judged incomplete (EPAR)", "result_source": "EPAR", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT02274181" }, { "nct": "NCT00962637", "code": "ZA-003", "sponsor": "Repros Therapeutics Inc.", "category": "safety", "phase": "3", "allocation": "RANDOMIZED", "masking": "DOUBLE", "enrolment": 194, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2006-03", "completion": "2007-05", "results_posted": false, "results_first_posted": null, "primary_endpoint": "Safety over 6 months (efficacy: morning testosterone in range vs placebo and testosterone comparator)", "primary_result": "Testosterone in range more often than placebo (p<0.0001), not different from testosterone comparator; patient-reported sexual outcomes showed no benefit over placebo", "result_source": "EPAR", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT00962637" }, { "nct": "NCT01067365", "code": "ZA-003 Extension Study", "sponsor": "Repros Therapeutics Inc.", "category": "safety", "phase": "3", "allocation": "NON_RANDOMIZED", "masking": "NONE", "enrolment": 104, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2006-03", "completion": "2007-05", "results_posted": false, "results_first_posted": null, "primary_endpoint": "Safety over 12 months (extension of ZA-003)", "primary_result": "Summarised in EPAR only", "result_source": "EPAR", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT01067365" }, { "nct": "NCT01386567", "code": "ZA-203 Extension", "sponsor": "Repros Therapeutics Inc.", "category": "safety", "phase": "2", "allocation": "NON_RANDOMIZED", "masking": "NONE", "enrolment": 48, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2011-07", "completion": "2013-01", "results_posted": false, "results_first_posted": null, "primary_endpoint": "Testosterone over 1 year, open label, vs testosterone comparator", "primary_result": "Summarised in EPAR only (Table 62: testosterone over 12 months; 48 of 124 ZA-203 participants recruited)", "result_source": "EPAR", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT01386567" }, { "nct": "NCT01534208", "code": "ZA-300", "sponsor": "Repros Therapeutics Inc.", "category": "safety", "phase": "3", "allocation": "NON_RANDOMIZED", "masking": "NONE", "enrolment": 499, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2012-05", "completion": "2013-10", "results_posted": true, "results_first_posted": "2014-07-24", "primary_endpoint": "Change in morning testosterone, LH at 26 weeks (open-label safety)", "primary_result": "Testosterone and LH rose from baseline (uncontrolled)", "result_source": "CT.gov", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT01534208" }, { "nct": "NCT01619683", "code": "ZA-303", "sponsor": "Repros Therapeutics Inc.", "category": "safety", "phase": "3", "allocation": "NON_RANDOMIZED", "masking": "SINGLE", "enrolment": 300, "enrolment_type": "ACTUAL", "status": "COMPLETED", "start": "2012-09", "completion": "2014-09", "results_posted": false, "results_first_posted": null, "primary_endpoint": "Bone mineral density at 52 weeks vs placebo", "primary_result": "Sponsor 10-K: no negative effect on BMD; EPAR result tables not text-extractable", "result_source": "EPAR + sponsor 10-K", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT01619683" }, { "nct": "NCT01739582", "code": "ZA-301EXT", "sponsor": "Repros Therapeutics Inc.", "category": "safety", "phase": "3", "allocation": "NON_RANDOMIZED", "masking": "NONE", "enrolment": 300, "enrolment_type": "ESTIMATED", "status": "COMPLETED", "start": "2012-11", "completion": "2014-04", "results_posted": false, "results_first_posted": null, "primary_endpoint": "Testosterone at 26 weeks (extension of ZA-301)", "primary_result": "Summarised in EPAR only (Table 65; testosterone rose at all visits and fell one month after stopping)", "result_source": "EPAR", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT01739582" }, { "nct": "NCT02117830", "code": "ZA-108", "sponsor": "Repros Therapeutics Inc.", "category": "safety", "phase": "1", "allocation": "RANDOMIZED", "masking": "QUADRUPLE", "enrolment": 54, "enrolment_type": "ESTIMATED", "status": "COMPLETED", "start": "2014-04", "completion": "2014-05", "results_posted": false, "results_first_posted": null, "primary_endpoint": "Thorough QT/QTc", "primary_result": "Summarised in EPAR only", "result_source": "EPAR", "pubmed": null, "pubmed_certainty": null, "summarised_in_epar": true, "url": "https://clinicaltrials.gov/study/NCT02117830" } ] }