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Last Updated: November 19, 2019

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CLINICAL TRIALS PROFILE FOR TESTOSTERONE

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505(b)(2) Clinical Trials for Testosterone

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00626431 A Study of Leuprolide to Treat Prostate Cancer Completed Abbott Phase 3 2008-02-01 To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A formulation will be deemed successful if the percentage of subjects with suppression of testosterone to <= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of the 2-sided 90% confidence interval), a protocol-specified criterion.
New Formulation NCT04060043 Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer Completed Peptigroupe Inc Early Phase 1 2017-02-21 This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.
New Formulation NCT04060043 Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer Completed CMX Research Early Phase 1 2017-02-21 This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Testosterone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000175 The Effects of Sex Hormones on Cognition and Mood in Older Adults Terminated National Institute on Aging (NIA) N/A 1969-12-31 This study is investigating the effects of hormone replacement therapy on memory, mental abilities and mood in older adults aged 65-90. During the nine month long study, men will take testosterone for three months and women will take estrogen for three months. At four points during the study (once every three months), participants will complete a test battery and have blood drawn.
NCT00000177 Estrogen Hormone Protocol Completed National Institute on Aging (NIA) Phase 3 1995-10-01 Estrogen is a hormone that is dominant in the female reproductive system. In women, most estrogen is produced by the ovaries. Men produce estrogen by converting testosterone into estrogen. Because this hormone also has many beneficial effects on brain cells, it currently is being studied as a treatment for Alzheimer's disease. The enzyme that forms the neurotransmitter acetylcholine is promoted in the presence of estrogen. Several very small clinical studies have demonstrated improvement in cognitive function and mood measures in women with Alzheimer's disease who take estrogen.
NCT00000854 A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 The purpose of this study is to see if giving nandrolone decanoate (a hormonal drug) will cause weight gain in HIV-positive women who have HIV-associated weight loss (wasting). Wasting has become an AIDS-defining condition. In the past, most studies that examined wasting treatments were limited to men. However, it appears that wasting in HIV-positive men is linked to levels of testosterone (a hormone which affects men's bodies more than women's). This study has been designed for women only, in order to best treat wasting in HIV-positive women.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Testosterone

Condition Name

Condition Name for Testosterone
Intervention Trials
Prostate Cancer 160
Hypogonadism 123
Polycystic Ovary Syndrome 47
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Condition MeSH

Condition MeSH for Testosterone
Intervention Trials
Prostatic Neoplasms 232
Hypogonadism 189
Polycystic Ovary Syndrome 55
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Clinical Trial Locations for Testosterone

Trials by Country

Trials by Country for Testosterone
Location Trials
Canada 109
United Kingdom 54
Germany 41
Australia 34
Brazil 24
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Trials by US State

Trials by US State for Testosterone
Location Trials
California 140
Texas 137
New York 111
Massachusetts 99
Florida 89
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Clinical Trial Progress for Testosterone

Clinical Trial Phase

Clinical Trial Phase for Testosterone
Clinical Trial Phase Trials
Phase 4 134
Phase 3 148
Phase 2/Phase 3 31
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Clinical Trial Status

Clinical Trial Status for Testosterone
Clinical Trial Phase Trials
Completed 403
Recruiting 150
Not yet recruiting 99
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Clinical Trial Sponsors for Testosterone

Sponsor Name

Sponsor Name for Testosterone
Sponsor Trials
National Cancer Institute (NCI) 59
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 43
University of Washington 36
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Sponsor Type

Sponsor Type for Testosterone
Sponsor Trials
Other 854
Industry 363
NIH 178
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