55 completed, 5 recruiting, 4 unknown, 3 withdrawn. 72 Phase 3, 6 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 72 | Completed 55, Recruiting 5, Unknown 4, Withdrawn 3, Not yet recruiting 2, Terminated 2, Active not recruiting 1 |
| Phase 2 | 6 | Completed 3, Withdrawn 2, Not yet recruiting 1 |
Follow Hypogonadism: new trials by email Literature Review of Hypogonadism trials Research Report on 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 |
|---|---|---|---|---|---|---|
| Testosterone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial testosterone cypionate, finasteride, placebo injection - Spinal Cord Injury, Spinal Cord Injuries | Phase 2 / Phase 3 | Not yet recruiting | VA Office of Research and Development | 300 | 2027-10-01 | 2026-08-04 |
| SEMAFORCRANIO : Multicenter, Double-blind, Parallel, Randomized Controlled Trial of the Efficacy of Semaglutide in Hypothalamic Obesity Secondary to Craniopharyngioma in Children Aged 12 to 17 Years Semaglutide (Wegovy) weekly injection, Placebo weekly Injection - Craniopharyngioma, Child | Phase 3 | Not yet recruiting | University Hospital, Angers | 50 | 2026-11-01 | 2026-09-29 |
| Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With Hypogonadism Testosterone Cypionate 75 mg, Testosterone cypionate 50 mg, Testosterone cypionate 100 mg - Male Hypogonadism | Phase 3 | Recruiting | Amneal Pharmaceuticals, LLC | 190 | 2026-09-28 | 2026-10-27 |
| A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756) Setmelanotide, Placebo - Hypothalamic Obesity, Multiple Pituitary Hormone Deficiency Genetic Form | Phase 3 | Recruiting | Rhythm Pharmaceuticals, Inc. | 39 | 2025-09-23 | 2026-02-12 |
| 52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism Testosterone enanthate - Hypogonadism, Male | Phase 3 | Recruiting | Halozyme Therapeutics | 100 | 2025-03-07 | 2026-11-06 |
| Open-Label Extension Study of Setmelanotide Setmelanotide - Obesity Associated With Defects in Leptin-melanocortin Pathway | Phase 3 | Completed | Rhythm Pharmaceuticals, Inc. | 28 | 2024-10-21 | 2026-07-15 |
| A Trial of Setmelanotide in Acquired Hypothalamic Obesity Setmelanotide, Placebo - Hypothalamic Obesity | Phase 3 | Active not recruiting | Rhythm Pharmaceuticals, Inc. | 143 | 2023-04-26 | 2026-08-10 |
| Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome Anastrozole, Semaglutide, human chorionic gonadotropin - Klinefelter Syndrome | Phase 3 | Recruiting | Georgios Papadakis | 150 | 2023-03-21 | 2026-05-11 |
| Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy Testosterone gel, Placebo - Prostatic Neoplasms, Hypogonadism | Phase 3 | Recruiting | Canisius-Wilhelmina Hospital | 140 | 2022-12-12 | 2025-05-02 |
| Testopel ® vs. Generic Testosterone Pellets. Testopel 75mg Drug Implant, Testopel 100mg Drug Implant, Testopel 200mg Drug Implant - Hypogonadism | Phase 3 | Completed | University of Miami | 75 | 2020-03-12 | 2023-08-14 |
| Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men SOV2012-F1 - Hypogonadism, Male | Phase 3 | Completed | Marius Pharmaceuticals | 155 | 2018-09-18 | 2024-06-28 |
| Efficacy and Safety of Testosterone Nasal Gel for Treating Hypogonadism in Men. Nasotestt 5 mg, Androgel 50 mg, Nasotestt Placebo - Hypogonadism | Phase 3 | Unknown | FBM Industria Brasileira Ltda | 228 | 2018-07-16 | 2017-09-19 |
| Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men LPCN 1021 - Hypogonadism, Male | Phase 3 | Completed | Lipocine Inc. | 138 | 2018-04-30 | 2021-06-10 |
| Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men SOV2012-F1, AndroGel - Hypogonadism, Male | Phase 3 | Completed | Marius Pharmaceuticals | 314 | 2017-07-05 | 2023-06-28 |
| Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolescent Males With Hypogonadotropic Hypogonadism (HH) (MK-8962-043) Corifollitropin alfa, hCG - Hypogonadotropic Hypogonadism | Phase 3 | Completed | Organon and Co | 17 | 2017-02-02 | 2024-05-23 |
| Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy Exenatide, Placebo - Craniopharyngiomas, Hypothalamic Obesity | Phase 3 | Completed | University Hospital, Bordeaux | 42 | 2017-01-11 | 2026-05-22 |
| Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) LPCN 1021 - Hypogonadism, Male | Phase 3 | Completed | Lipocine Inc. | 100 | 2017-01-01 | 2019-10-23 |
| Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021). LPCN 1021 - Hypogonadism, Male | Phase 3 | Completed | Lipocine Inc. | 95 | 2016-12-01 | 2019-10-23 |
| Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After a Recent Myocardial Infarction Testosterone, Normal Saline - Hypogonadism, Acute Myocardial Infarction: Rehabilitation Phase | Phase 2 / Phase 3 | Withdrawn | Texas Tech University Health Sciences Center | 2016-08-01 | 2019-11-21 | |
| A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men Oral Testosterone Undecanoate, Axiron Testosterone Topical Solution - Hypogonadism | Phase 3 | Completed | Clarus Therapeutics, Inc. | 222 | 2016-03-01 | 2018-02-23 |
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Eunuchism (16) · Obesity (6) · Sexual Infantilism (6) · Infertility (3) · Metabolic Syndrome (3) · Prostatic Neoplasms (3) · Craniopharyngioma (2) · Endocrine System Diseases (2) · Erectile Dysfunction (2) · Gonadal Disorders (2) · Klinefelter Syndrome (2) · Spinal Cord Injuries (2) · Weight Loss (2) · Bone Diseases (1)
Endocrine System Diseases (70) · Gonadal Disorders (70) · Urogenital Diseases (15) · Male Urogenital Diseases (14) · Nutritional and Metabolic Diseases (10) · Congenital Abnormalities (9) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (9) · Disorders of Sex Development (9) · Female Urogenital Diseases (9) · Female Urogenital Diseases and Pregnancy Complications (9) · Genital Diseases (9) · Urogenital Abnormalities (9) · Gonadal Dysgenesis (7) · Body Weight (6)
Testosterone (19) · testosterone undecanoate (12) · Enclomiphene (9) · Testosterone Propionate (9) · setmelanotide (3) · testosterone 17 beta-cypionate (3) · testosterone enanthate (3) · Alendronate (2) · Chorionic Gonadotropin (2) · Estradiol (2) · Exenatide (2) · Sodium Chloride (2) · follicle stimulating hormone, human, with HCG C-terminal peptide (2) · semaglutide (2) · Anastrozole (1)
Repros Therapeutics Inc. (8) · Clarus Therapeutics, Inc. (4) · Lipocine Inc. (4) · Eli Lilly and Company (3) · Endo USA Inc., a Keenova Therapeutics Company (3) · Ferring Pharmaceuticals (3) · Rhythm Pharmaceuticals, Inc. (3) · VA Office of Research and Development (3) · Amneal Pharmaceuticals, LLC (2) · Antares Pharma Inc. (2) · Ardana Bioscience Ltd (2) · Marius Pharmaceuticals (2) · Organon and Co (2) · AbbVie (1) · Abbott (1)
United States (45) · Germany (7) · France (5) · Canada (4) · United Kingdom (4) · Italy (3) · Netherlands (3) · Switzerland (3) · Australia (2) · China (2) · Russia (2) · Spain (2) · Argentina (1) · Brazil (1) · Denmark (1)
Ronald Swerdloff, MD (4) · Anthony DelConte, MD (3) · David Meeker, MD (3) · Joseph S Podolski (3) · Andre van As, MD, PhD (2) · Om Dhingra, PhD (2) · Alastair Smith, MB, ChB (1) · Alessandro Silva, Director (1) · Alistair Smith, MB, ChB (1) · Andrea Isidori, MD, PhD (1) · Andrea Lenzi, MD (1)
PMID 38224135, PMID 36272969, PMID 38606384, PMID 17371886, PMID 20524974, PMID 20718771, PMID 21252493, PMID 21689131, PMID 21717386, PMID 22321357, PMID 23343764, PMID 24968251, PMID 24978674, PMID 26498057, PMID 26549704, PMID 26695758, PMID 28270212, PMID 29939279, PMID 31042669, PMID 31532522, PMID 31551193, PMID 32275191, PMID 33846498, PMID 34191621, PMID 34375393, PMID 34994093, PMID 38433502, PMID 38450721, PMID 39252657, PMID 40514343, PMID 42418774, PMID 42528856, PMID 42821228
2015 (1), R01DK061536 (1)