30 completed, 5 terminated, 4 withdrawn, 2 recruiting. 14 Phase 2, 9 Phase 3, 9 Phase 4, 8 Phase 1, 5 Not applicable.
Follow AndroGel: new trials by email Literature Review of AndroGel trials Research Report on AndroGel
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 |
|---|---|---|---|---|---|---|
| Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc stereotactic ablative radiotherapy, Pluvicto, topical testosterone - Prostate Cancer | Phase 2 | Recruiting | VA Office of Research and Development | 60 | 2023-12-14 | 2025-12-31 |
| 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 |
| Testosterone & Tamoxifen Trial AndroGel - Male Breast Cancer | Not applicable | Terminated | University Medical Center Groningen | 5 | 2022-11-10 | 2024-08-09 |
| Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening Progesterone, Ibutilide, Testosterone - Long QT Syndrome, Abnormalities, Drug-Induced | Phase 4 | Completed | Indiana University | 73 | 2021-09-02 | 2026-10-20 |
| Testosterone Treatment in a Patient With 17β-hydroxysteroid Dehydrogenase Type 3 Deficiency: an N-of-1 Study Testosterone gel, Placebo - Disorder of Sex Development, 46,XY | Phase 3 | Unknown | Erasmus Medical Center | 1 | 2021-06-01 | 2021-04-05 |
| Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality AndroGel - Hypogonadism | Phase 2 | Completed | Lars Møller Pedersen | 7 | 2021-04-01 | 2022-11-29 |
| Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism Testosterone gel 1.62%, Placebo - Type 2 Diabetes Mellitus, Hypogonadism | Phase 4 | Completed | VA Office of Research and Development | 92 | 2019-10-01 | 2026-04-29 |
| ITT-5 Mechanisms of Spermatogenesis in Man Testosterone 1% Gel, Acyline, Dutasteride - Gonadotropin Deficiency | Phase 2 | Withdrawn | University of Washington | 2019-06-01 | 2019-12-18 | |
| Short-term Testosterone Replacement in Testicular Cancer Survivors Androgel (Testosterone gel), Placebo gel - Testicular Cancer | Phase 2 | Completed | University Medical Center Groningen | 32 | 2018-12-21 | 2024-07-30 |
| Comparison Between Testosterone and Estradiol Over the Homogenization of Follicular Cohort Testosterone, Estradiol - Fertility Disorders | Phase 3 | Unknown | Hospital de Clinicas de Porto Alegre | 26 | 2017-08-01 | 2017-08-03 |
| 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 |
| Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes Testosterone, Progesterone, Placebo - Long QT Syndrome | Phase 4 | Completed | Indiana University | 14 | 2016-05-01 | 2019-08-28 |
| Testosterone Gel in Poor Responders Undergoing IVF Testosterone gel, DHEA - Infertility | Not applicable | Withdrawn | Vietnam National University | 2015-09-01 | 2017-04-18 | |
| Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men Nestorone® /testosterone gel, Testosterone only gel - Healthy | Phase 1 | Completed | Kimberly Myer | 44 | 2015-04-01 | 2025-02-13 |
| Hormonal Mechanisms of Sleep Restriction Ketoconazole, Hydrocortisone, Testosterone - Insulin Resistance | Early Phase 1 | Completed | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | 40 | 2014-10-01 | 2025-09-11 |
| T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin Acyline, Testosterone 1.62% gel, Letrozole - Insulin Resistance, Type 2 Diabetes Mellitus | Phase 1 / Phase 2 | Completed | University of Washington | 53 | 2013-06-01 | 2018-05-08 |
| Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men Oral testosterone undecanoate, Transdermal testosterone gel (AndroGel) - Male Hypogonadism | Phase 3 | Completed | Clarus Therapeutics, Inc. | 182 | 2012-08-01 | 2021-06-28 |
| PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate placebo acyline, placebo gel, Testosterone 1% gel 1.25 g - Healthy | Phase 2 / Phase 3 | Completed | University of Washington | 62 | 2011-10-01 | 2017-10-05 |
| 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 |
| ITT4 Intratesticular Hormonal Milieu in Man (ITT4) Acyline, Testosterone gel, ketoconazole 400 - Healthy Males | Phase 1 / Phase 2 | Completed | University of Washington | 46 | 2011-01-01 | 2014-03-31 |
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Hypogonadism (19) · Insulin Resistance (5) · Neoplasms (5) · Obesity (5) · Prostatic Neoplasms (4) · Diabetes Mellitus (3) · Diabetes Mellitus, Type 2 (3) · Metabolic Syndrome (3) · Eunuchism (2) · Long QT Syndrome (2) · Abnormalities, Drug-Induced (1) · Breast Neoplasms, Male (1) · Depression (1) · Depressive Disorder (1) · Depressive Disorder, Major (1)
University of Washington (5) · Massachusetts General Hospital (3) · Indiana University (2) · Memorial Sloan Kettering Cancer Center (2) · Repros Therapeutics Inc. (2) · University Medical Center Groningen (2) · University at Buffalo (2) · VA Office of Research and Development (2) · Acerus Pharmaceuticals Corporation (1) · Boston University (1) · Canisius-Wilhelmina Hospital (1) · Clarus Therapeutics, Inc. (1) · Diabetes Center of the Southwest (1) · Erasmus Medical Center (1) · Hospital de Clinicas de Porto Alegre (1)
United States (32) · Netherlands (5) · Denmark (1) · Germany (1) · Israel (1) · Italy (1) · Vietnam (1)
James E Tisdale, PharmD (2) · Stephanie T Page, MD, PhD (2) · William J Bremner, MD, PhD (2) · Alastair Smith, MB, ChB (1) · Alvin M Matsumoto, MD (1) · Andre van As, MD, PhD (1) · Andrea Lenzi, MD, PhD (1) · Andrea M Isidori, MD, PhD (1) · Ben Z Leder, MD (1) · Christina Wang, MD (1) · Dana Rathkopf, MD, PhD (1) · Diederik Somford, MD, PhD (1) · Ellen F. Binder, MD (1) · Frances J Hayes, MD (1) · Fred R Sattler, MD (1)
PMID 19653976, PMID 20520285, PMID 21575967, PMID 22939385, PMID 23348398, PMID 24024838, PMID 25044085, PMID 25392748, PMID 25599449, PMID 26901812, PMID 27172434, PMID 27482750, PMID 27992261, PMID 28981994, PMID 29793828, PMID 30353813, PMID 30898204, PMID 32480409, PMID 33020898, PMID 33718653, PMID 34043794, PMID 35665818, PMID 36171900, PMID 36272969, PMID 38606384, PMID 39668628, PMID 40514343
I01CX001665 (1), I01CX002775 (1), R01AG019339 (1), R01AG030545 (1), R01AG037603 (1), R01DK045343 (1), R01HL153114 (1), U54HD012629 (1)