18 completed, 1 enrolling by invitation, 1 not yet recruiting, 1 unknown. 9 Phase 3, 6 Phase 2, 3 Phase 1, 2 Not applicable, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 9 | Completed 9 |
| Phase 2 | 6 | Completed 5, Unknown 1 |
| Phase 1 | 3 | Completed 3 |
| Not applicable | 2 | Enrolling by invitation 1, Not yet recruiting 1 |
| Phase 4 | 1 | Completed 1 |
Follow Secondary Hypogonadism: new trials by email Literature Review of Secondary Hypogonadism trials Research Report on Secondary Hypogonadism
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| AIM-TEST: Microbiome-Targeted Nutrition for Functional Secondary Hypogonadism Fixed-Formula Microbiome-Targeted Oral Nutritional Supplement, Matched Oral Placebo - Hypogonadism, Male, Secondary Hypogonadism | Not applicable | Enrolling by invitation | Varol TUNALI | 112 | 2026-08-15 | 2026-09-29 |
| Intratesticular Artery Resistive Index Changes After Varicocelectomy Microscopic Sub-inguinal Varicocelectomy - Varicocele, Male Infertility | Not applicable | Not yet recruiting | Assiut University | 40 | 2026-05-01 | 2026-04-08 |
| Safety and Efficacy Study of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men fispemifene, Placebo - Secondary Hypogonadism, Sexual Dysfunction | Phase 2 | Unknown | NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.) | 160 | 2015-05-01 | 2015-11-13 |
| 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 Androxal - Secondary Hypogonadism | Phase 1 | Completed | Repros Therapeutics Inc. | 6 | 2014-12-01 | 2015-03-12 |
| 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% Androxal 12.5 mg/25 mg, Placebo Capsules, AndroGel 1.62% - Secondary Hypogonadism | Phase 3 | Completed | Repros Therapeutics Inc. | 120 | 2014-01-01 | 2014-10-01 |
| 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% Androxal 12.5 mg or 25 mg, AndroGel 1.62%, Placebo Capsules - Secondary Hypogonadism | Phase 3 | Completed | Repros Therapeutics Inc. | 120 | 2014-01-01 | 2014-10-01 |
| Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function Androxal 25 mg - Secondary Hypogonadism | Phase 1 | Completed | Repros Therapeutics Inc. | 19 | 2013-08-01 | 2014-01-24 |
| Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function Androxal 25 mg - Secondary Hypogonadism | Phase 1 | Completed | Repros Therapeutics Inc. | 26 | 2013-08-01 | 2014-08-11 |
| Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism enclomiphene citrate, Placebo - Secondary Hypogonadism | Phase 3 | Completed | Repros Therapeutics Inc. | 181 | 2012-11-01 | 2015-05-27 |
| An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism Androxal - Secondary Hypogonadism | Phase 3 | Completed | Repros Therapeutics Inc. | 300 | 2012-11-01 | 2014-04-16 |
| Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism Androxal, Placebo - Secondary Hypogonadism | Phase 3 | Completed | Repros Therapeutics Inc. | 151 | 2012-08-01 | 2015-05-27 |
| Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism Androxal - Secondary Hypogonadism | Phase 3 | Completed | Repros Therapeutics Inc. | 499 | 2012-05-01 | 2014-07-24 |
| The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone) Androxal (enclomiphene citrate), Testosterone - Secondary Hypogonadism | Phase 2 | Completed | Repros Therapeutics Inc. | 60 | 2011-06-01 | 2015-09-23 |
| Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism Placebo, topical testosterone, Androxal - Secondary Hypogonadism | Phase 2 | Completed | Repros Therapeutics Inc. | 83 | 2011-01-01 | 2014-07-28 |
| Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus Placebo, Androxal - Type 2 Diabetes Mellitus, Secondary Hypogonadism | Phase 2 | Completed | Repros Therapeutics Inc. | 102 | 2010-10-01 | 2014-07-24 |
| Pharmacokinetic Study to Determine Time to Steady-state Testosterone undecanoate - Male Hypogonadism, Primary Hypogonadism | Phase 2 | Completed | Clarus Therapeutics, Inc. | 15 | 2009-07-01 | 2020-12-11 |
| The Effect of Testosterone Replacement on the High Density Lipoprotein Cholesterol Subgroups Testosteron 250mg injection, Testosterone 50mg transdermal application - Secondary Hypogonadism | Phase 4 | Completed | Gulhane School of Medicine | 140 | 2008-09-01 | 2011-10-18 |
| To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone 25 mg Androxal, Testim 1% - Secondary Hypogonadism | Phase 2 | Completed | Repros Therapeutics Inc. | 17 | 2008-06-01 | 2015-08-19 |
| Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism Androxal, AndroGel, Placebo - Secondary Hypogonadism | Phase 3 | Completed | Repros Therapeutics Inc. | 194 | 2006-03-01 | 2010-02-11 |
| Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism Androxal - Secondary Hypogonadism | Phase 3 | Completed | Repros Therapeutics Inc. | 104 | 2006-03-01 | 2014-06-27 |
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Hypogonadism (21) · Erectile Dysfunction (2) · Eunuchism (2) · Diabetes Mellitus, Type 2 (1) · Infertility, Male (1) · Sexual Dysfunction, Physiological (1) · Varicocele (1)
Endocrine System Diseases (21) · Gonadal Disorders (21) · Genital Diseases (3) · Genital Diseases, Male (3) · Male Urogenital Diseases (3) · Urogenital Diseases (3) · Mental Disorders (2) · Sexual Dysfunctions, Psychological (2) · Cardiovascular Diseases (1) · Diabetes Mellitus (1) · Glucose Metabolism Disorders (1) · Infertility (1) · Metabolic Diseases (1) · Nutritional and Metabolic Diseases (1) · Sexual Dysfunction, Physiological (1)
Enclomiphene (15) · Testosterone (5) · testosterone undecanoate (2) · Injections (1) · Testosterone Propionate (1) · fispemifene (1)
Repros Therapeutics Inc. (15) · Assiut University (1) · Clarus Therapeutics, Inc. (1) · Endo USA Inc., a Keenova Therapeutics Company (1) · Gulhane School of Medicine (1) · NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.) (1) · Varol TUNALI (1)
United States (17) · Turkey (Türkiye) (2)
Joseph S Podolski (3) · Andre van As, MD, PhD (2) · Barbara Cook, MD (1) · Barbara Troupin, MD, MBA (1) · Glenn Cunningham, MD (1) · Gregory Flippo, MD (1) · Jolene Berg, MD (1) · Larry Lipshultz, MD (1) · Ronald Wiehle, PhD (1)