48 completed, 6 unknown, 5 recruiting, 3 terminated. 25 Phase 2, 17 Phase 3, 16 Phase 4, 5 Not applicable, 4 Phase 1.
Follow testosterone undecanoate: new trials by email Literature Review of testosterone undecanoate trials Research Report on testosterone undecanoate
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 |
|---|---|---|---|---|---|---|
| Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency Nebido (Testosterone Undecanoate) - Frail Elderly Patients, Hypogonadal Males | Phase 2 | Not yet recruiting | Rune Skovgaard Rasmussen | 96 | 2026-08-01 | 2026-05-06 |
| Testosterone-induced Muscle Memory and Underlying Mechanisms Testosterone Undecanoate - Skeletal Muscle Physiology | Not applicable | Recruiting | Morten Hostrup, PhD | 30 | 2025-04-01 | 2025-04-10 |
| An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD Oral Testosterone Undecanoate - Hypoactive Sexual Desire Disorder | Phase 2 | Not yet recruiting | San Diego Sexual Medicine | 30 | 2025-01-01 | 2024-11-13 |
| Comparing Direct and Indirect Detection Methods of Multiple Routes of Testosterone Administration Testosterone injection, Testosterone gel, Testosterone Oral - Healthy | Early Phase 1 | Completed | Sports Medicine Research and Testing Laboratory | 14 | 2024-11-27 | 2024-12-03 |
| Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone? Saline, Testosterone Undecanoate, Saline + Resistance exercise training - Healthy Aging, Age-Related Sarcopenia | Phase 2 / Phase 3 | Completed | Norwegian School of Sport Sciences | 45 | 2024-09-01 | 2026-03-06 |
| Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17 Relugolix 120Mg Tab, Curcumin, Testosterone Undecanoate 237 MG Oral Capsule - Hypogonadism, Male | Phase 1 / Phase 2 | Unknown | University of Washington | 10 | 2024-06-01 | 2024-03-15 |
| Early Mental Response - The EMRE Study Testosterone treatment, Placebo treatment - Gender Dysphoria, Gender Identity | Not applicable | Recruiting | Karolinska University Hospital | 70 | 2023-03-07 | 2023-03-08 |
| Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer Testosterone Undecanoate, Enzalutamide - Prostate Cancer, Castration-resistant Prostate Cancer | Phase 2 | Active not recruiting | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 15 | 2022-03-07 | 2026-09-29 |
| Testosterone Undecanoate Replacement Therapy in Boys With Pubertal Delay or Confirmed Hypogonadism Testosterone Undecanoate - Delayed Puberty, Male Hypogonadism | Unknown | Hospital de Niños R. Gutierrez de Buenos Aires | 27 | 2022-03-01 | 2024-02-28 | |
| Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism Testosterone Undecanoate, Placebo - Fatty Liver, Overweight/Obesity | Phase 4 | Recruiting | Alexandra Kautzky-Willer | 32 | 2022-01-25 | 2024-03-13 |
| Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism Testosterone Undecanoate 250 MG/ML, Placebo - Opioid Use, Pain | Phase 2 | Recruiting | Brigham and Women's Hospital | 150 | 2022-01-10 | 2026-07-27 |
| Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED], placebo - Hypogonadism, Male, Fatigue Syndrome, Chronic | Phase 2 | Recruiting | Seattle Institute for Biomedical and Clinical Research | 240 | 2021-03-22 | 2026-06-22 |
| Testosterone in Bariatric Patients Testosterone Undecanoate - Bariatric Surgery Candidate, Male Hypogonadism | Phase 4 | Completed | Esbjerg Hospital - University Hospital of Southern Denmark | 64 | 2020-12-17 | 2026-09-11 |
| A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial LPCN 1144 - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Lipocine Inc. | 25 | 2020-11-11 | 2024-07-17 |
| The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With Type 2 Diabetes Mellitus and Obesity Semaglutide, Testosterone Undecanoate - Type 2 Diabetes Mellitus, Obesity | Phase 3 | Completed | University Medical Centre Ljubljana | 25 | 2020-09-20 | 2024-07-08 |
| A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism Aveed Injectable Product, Fortesta, Testim - Hypogonadism, Hypogonadism, Male | Phase 4 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 673 | 2020-06-30 | 2025-03-14 |
| Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations Testosterone Undecanoate, Sesame Oil - Caloric Restriction, Exercise | Phase 4 | Completed | Pennington Biomedical Research Center | 34 | 2019-09-23 | 2022-10-07 |
| The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer Degarelix 120 MG [Firmagon], Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector, Testosterone Undecanoate - Prostate Cancer Recurrent | Not applicable | Completed | Lund University | 33 | 2019-09-16 | 2020-01-22 |
| The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis LPCN 1144 Formulation A, LPCN 1144 Formulation B, Placebo - Nonalcoholic Steatohepatitis (NASH) | Phase 2 | Completed | Lipocine Inc. | 56 | 2019-08-27 | 2023-12-14 |
| Multimodality Intervention for Function and Metabolism in SCI Testosterone Undecanoate, hybrid exercise - Spinal Cord Injuries | Phase 2 | Completed | Brigham and Women's Hospital | 84 | 2019-08-23 | 2026-05-07 |
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Hypogonadism (32) · Eunuchism (18) · Diabetes Mellitus, Type 2 (4) · Non-alcoholic Fatty Liver Disease (4) · Obesity (4) · Erectile Dysfunction (3) · Transsexualism (3) · Gender Dysphoria (2) · Heart Failure (2) · Insulin Resistance (2) · Metabolic Syndrome (2) · Puberty, Delayed (2) · Angina Pectoris (1) · Arteriosclerosis (1) · Carcinoma, Renal Cell (1)
Clarus Therapeutics, Inc. (11) · Bayer (4) · Lipocine Inc. (3) · Brigham and Women's Hospital (2) · Chulalongkorn University (2) · Endo USA Inc., a Keenova Therapeutics Company (2) · Sheffield Teaching Hospitals NHS Foundation Trust (2) · Unita Complessa di Ostetricia e Ginecologia (2) · University Medical Centre Ljubljana (2) · University of Roma La Sapienza (2) · Alexandra Kautzky-Willer (1) · Austin Health (1) · Esbjerg Hospital - University Hospital of Southern Denmark (1) · Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia (1) · Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (1)
United States (22) · United Kingdom (7) · Germany (6) · Denmark (4) · Italy (4) · Russia (4) · Australia (3) · Austria (3) · Spain (3) · Thailand (3) · Canada (2) · Latvia (2) · Mexico (2) · Norway (2) · Slovenia (2)
Ronald Swerdloff, MD (5) · Anthony DelConte (2) · Alexandra Kautzky-Willer, MD (1) · Andrea Isidori, MD, PhD (1) · Andrea Lenzi, MD (1) · Anthony DelConte, MD (1) · Antoni Bayes-Genis, MD, PhD (1) · Apichat Kongkanand, Professor (1) · Christina Wang, M.D. (1) · Cristina M Meriggiola, MD (1) · David Hernandez (1) · Dermot Gleeson, MD (1) · Domingo A Pascual-Figal, MD, PhD (1)
PMID 21474786, PMID 36272969, PMID 12626215, PMID 18308009, PMID 18413423, PMID 19144729, PMID 20524974, PMID 20718771, PMID 21700760, PMID 23581697, PMID 24978674, PMID 25497691, PMID 26030346, PMID 26631095, PMID 29929385, PMID 31532522, PMID 34278044, PMID 35614404, PMID 36796647, PMID 36949577, PMID 37124726, PMID 38088425, PMID 38224135, PMID 38325649, PMID 38433502, PMID 39252657, PMID 39511836, PMID 40279652
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