REPROS THERAPEUTICS INC. Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2016-07-26: Study NCT02811159; Company role Lead sponsor; Phase Phase 2; Status Terminated.
- 2016-01-11: Study NCT02651688; Company role Lead sponsor; Phase Phase 2; Status Completed.
- 2015-03-16: Study NCT02301897; Company role Lead sponsor; Phase Phase 2; Status Completed.
- 2015-02-12: Study NCT02323646; Company role Lead sponsor; Phase Phase 2; Status Completed.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2016-07-26 | NCT02811159 An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids | Lead sponsor | Phase 2 | Terminated Results posted | Uterine Fibroids | 20 | 2017-05-04 |
| 2016-01-11 | NCT02651688 A Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene | Lead sponsor | Phase 2 | Completed Results posted | Acquired Hypogonadotropic Hypogonadism; Obesity | 50 | 2017-05-02 |
| 2015-03-16 | NCT02301897 A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids | Lead sponsor | Phase 2 | Completed Results posted | Uterine Fibroids | 43 | 2017-06-02 |
| 2015-02-12 | NCT02323646 Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids | Lead sponsor | Phase 2 | Completed Results posted | Uterine Fibroids | 42 | 2017-04-06 |
| 2014-12 | NCT02274181 An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration | Lead sponsor | Phase 1 | Completed | Secondary Hypogonadism | 6 | 2015-01 |
| 2014-08 | NCT02169804 An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal | Lead sponsor | Phase 1 | Completed | Pharmacokinetics | 24 | 2014-08 |
| 2014-06 | NCT02146391 Study to Evaluate the Effect of Food Upon the Pharmacokinetics of Androxal | Lead sponsor | Phase 1 | Completed | Normal Volunteers | 12 | 2014-07 |
| 2014-05 | NCT02141061 Comparison of Two Formulations of Proellex for Oral Administration | Lead sponsor | Phase 1 | Completed | Healthy | 12 | 2014-06 |
| 2014-05 | NCT01991327 Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males | Lead sponsor | Phase 1 | Completed | Drug-drug Interaction | 30 | 2014-07 |
| 2014-04 | NCT02117830 A Thorough QT/QTc Study to Assess the Effects of Androxal in Healthy Male Subjects | Lead sponsor | Phase 1 | Completed | Healthy | 54 | |
| 2014-01 | NCT01993225 A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62% | Lead sponsor | Phase 3 | Completed | Secondary Hypogonadism | 120 | 2014-08 |
| 2014-01 | NCT01993212 A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62% | Lead sponsor | Phase 3 | Completed | Secondary Hypogonadism | 120 | 2014-09 |
| 2013-12-31 | NCT01984398 Comparison of Two Formulations of Androxal | Lead sponsor | Phase 1 | Completed Results posted | Bioequivalence | 16 | 2013-12-31 |
| 2013-12 | NCT01961908 Open-Label Extension Study to ZPE-202 | Lead sponsor | Phase 2 | Withdrawn | Endometriosis | 0 | 2014-12 |
| 2013-10 | NCT01962805 Comparison of Two Formulations of Proellex for Vaginal Administration | Lead sponsor | Phase 1 | Completed | Comparison of 2 Different Formulations of 12 mg Proellex Vaginal Capsules | 8 | 2013-12 |
| 2013-10 | NCT01959685 A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal | Lead sponsor | Phase 1 | Completed Results posted | Pharmacokinetics; Tolerability | 9 | 2013-11 |
| 2013-08 | NCT01923870 Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function | Lead sponsor | Phase 1 | Completed | Secondary Hypogonadism | 19 | 2014-01 |
| 2013-08 | NCT01923857 Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function | Lead sponsor | Phase 1 | Completed | Secondary Hypogonadism | 26 | 2014-08 |
| 2013-06 | NCT01800422 Oral CDB-4124 vs. Placebo in Stage I-II Primary Breast Cancer | Collaborator Lead: Northwestern University | Phase 2 | Unknown | Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer | 50 | 2022-03 |
| 2013-05-02 | NCT01728454 Safety and Efficacy of Telapristone Acetate (Proellex®) in the Treatment of Pre-Menopausal Women With Confirmed, Symptomatic Endometriosis | Lead sponsor | Phase 2 | Completed Results posted | Endometriosis | 60 | 2017-03-15 |
| 2012-11 | NCT01739595 Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism | Lead sponsor | Phase 3 | Completed Results posted | Secondary Hypogonadism | 181 | 2013-09 |
| 2012-11 | NCT01739582 An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism | Lead sponsor | Phase 3 | Completed | Secondary Hypogonadism | 300 | 2014-04 |
| 2012-09 | NCT01739621 Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200 | Lead sponsor | Phase 2 | Completed | Uterine Fibroids | 40 | 2014-04 |
| 2012-09 | NCT01631903 Extension of Study ZPV-200 | Lead sponsor | Phase 2 | Completed | Uterine Fibroids | 48 | 2014-04 |
| 2012-09 | NCT01619683 Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism | Lead sponsor | Phase 3 | Completed | Effect of Treatment on Bone Mineral Density | 300 | 2014-09 |
| 2012-08 | NCT01532414 Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism | Lead sponsor | Phase 3 | Completed Results posted | Secondary Hypogonadism | 151 | 2013-03 |
| 2012-05 | NCT01534208 Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism | Lead sponsor | Phase 3 | Completed Results posted | Secondary Hypogonadism | 499 | 2013-10 |
| 2012-02 | NCT01451424 Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids | Lead sponsor | Phase 2 | Completed Results posted | Uterine Fibroids | 40 | 2013-01 |
| 2011-07 | NCT01386567 A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203 | Lead sponsor | Phase 2 | Completed | Hypogonadism; Low Testosterone | 48 | 2013-01 |
| 2011-06 | NCT01386606 The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone) | Lead sponsor | Phase 2 | Completed Results posted | Secondary Hypogonadism | 60 | 2011-10 |
| 2011-01 | NCT01270841 Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism | Lead sponsor | Phase 2 | Completed Results posted | Secondary Hypogonadism | 83 | 2011-12 |
| 2010-10 | NCT01191320 Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus | Lead sponsor | Phase 2 | Completed Results posted | Type 2 Diabetes Mellitus; Secondary Hypogonadism | 102 | 2011-12 |
| 2010-08 | NCT01187043 Determination of the Lowest, Safe and Effective Dose of Proellex | Lead sponsor | Phase 1, Phase 2 | Completed Results posted | Amenorrhea | 52 | 2012-03 |
| 2009-04 | NCT01069120 Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids | Lead sponsor | Phase 3 | Terminated Results posted | Uterine Fibroids | 27 | 2009-08 |
| 2009-04 | NCT00881062 Investigate Absorption, Metabolism and Excretion of [14C}-Proellex Following Single Oral Dose in Healthy Females | Lead sponsor | Phase 1 | Completed | ABSORPTION; METABOLISM; EXCRETION | 6 | 2009-06 |
| 2009-02-28 | NCT00958412 Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study | Lead sponsor | Phase 2 | Terminated Results posted | Endometriosis | 18 | 2009-08-31 |
| 2009-02 | NCT00881608 Study to Evaluate Menses Induction in Women Administered Proellex | Lead sponsor | Phase 1 | Terminated Results posted | Amenorrhea | 11 | 2009-08 |
| 2009-02 | NCT00853567 Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids | Lead sponsor | Phase 3 | Terminated Results posted | Uterine Fibroids | 71 | 2009-08 |
| 2008-10 | NCT00787618 Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females | Lead sponsor | Phase 1, Phase 2 | Terminated Results posted | Renal Impairment | 6 | 2009-07 |
| 2008-10 | NCT00785356 Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids | Lead sponsor | Phase 3 | Terminated Results posted | Uterine Fibroids; Anemia | 8 | 2009-08 |
| 2008-10 | NCT00741273 Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults | Lead sponsor | Phase 1 | Completed Results posted | Impaired Liver Function | 16 | 2009-06 |
| 2008-10 | NCT00737282 Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids | Lead sponsor | Phase 3 | Terminated Results posted | Uterine Fibroids | 175 | 2009-08 |
| 2008-08-11 | NCT00749879 Crossover Study of the Safety and PK Properties of Proellex® | Lead sponsor | Phase 1 | Completed Results posted | Pharmacokinetics | 17 | 2008-10-23 |
| 2008-08 | NCT00735553 Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids | Lead sponsor | Phase 3 | Terminated Results posted | Uterine Fibroids | 77 | 2009-08 |
| 2008-07 | NCT00741468 Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects | Lead sponsor | Phase 1 | Completed Results posted | Drug Interactions | 18 | 2008-10 |
| 2008-06 | NCT00958893 An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext | Lead sponsor | Phase 2 | Terminated Results posted | Uterine Fibroids | 4 | 2009-08 |
| 2008-06 | NCT00706719 To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone | Lead sponsor | Phase 2 | Completed Results posted | Secondary Hypogonadism | 17 | 2009-08 |
| 2008-06 | NCT00702702 Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine Fibroids | Lead sponsor | Phase 3 | Terminated Results posted | Uterine Fibroids; Anemia | 56 | 2009-08 |
| 2008-05 | NCT00683917 Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids | Lead sponsor | Phase 2 | Terminated Results posted | Uterine Fibroids | 10 | 2009-08 |
| 2008-02-29 | NCT00620503 Proellex® Pharmacokinetic Bridging Study II | Lead sponsor | Phase 1 | Completed Results posted | Healthy | 12 | 2008-04-30 |
| 2008-02 | NCT00619385 A Safety and Pharmacokinetic Study of Proellex® | Lead sponsor | Phase 1 | Completed Results posted | Healthy | 25 | 2008-10 |
| 2007-11 | NCT00556075 Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis | Lead sponsor | Phase 2 | Terminated Results posted | Endometriosis | 67 | 2009-07 |
| 2007-06 | NCT01067807 Proellex Pharmacokinetics Bridging Study | Lead sponsor | Phase 1 | Completed | Healthy | 21 | 2007-07 |
| 2006-09-07 | NCT00958334 Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003 | Lead sponsor | Phase 2 | Completed Results posted | Uterine Fibroids | 65 | 2008-10-15 |
| 2006-03 | NCT01067365 Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism | Lead sponsor | Phase 3 | Completed | Secondary Hypogonadism | 104 | 2007-05 |
| 2006-03 | NCT00962637 Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism | Lead sponsor | Phase 3 | Completed | Secondary Hypogonadism | 194 | 2007-05 |
| 2006-03 | NCT00882258 Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids | Lead sponsor | Phase 2 | Completed | Uterine Fibroids | 144 | 2007-03 |
| 2004-07 | NCT01069094 A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata | Lead sponsor | Phase 1, Phase 2 | Completed | Uterine Leiomyomata | 29 | 2005-01 |
| NCT00874302 Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms | Lead sponsor | Phase 3 | Withdrawn | Uterine Fibroids | 0 |