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Last Updated: January 21, 2021

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CLINICAL TRIALS PROFILE FOR DEPO-ESTRADIOL

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505(b)(2) Clinical Trials for Depo-estradiol

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 NCT00649896 Evaluation of Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System 0.025 mg/Day and Climara® Transdermal System 0.025 mg/Day Completed Mylan Pharmaceuticals Phase 1 2003-08-01 The primary objective of this study was to compare the adhesive quality of a new formulation of the Mylan Estradiol Transdermal System with that of Climara® Transdermal System following a single system application in 80 healthy postmenopausal female volunteers. As a secondary objective, primary dermal irritation was assessed after removal of each transdermal system.
New Formulation NCT02253173 Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women Completed TherapeuticsMD Phase 3 2014-09-01 This study will assess the safety and efficacy of a new formulation of vaginal estradiol for the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.
OTC NCT02516202 The Vaginal Health Trial Recruiting Group Health Cooperative Phase 4 2016-04-01 This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Depo-estradiol

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000559 Women's Estrogen/Progestin Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1995-03-01 To determine the effects, in postmenopausal women, of hormone replacement therapy on progression/regression of coronary heart disease, as measured by quantitative angiography.
NCT00000897 A Study to Evaluate the Effects of Different Methods of Birth Control on the Drug Actions of Zidovudine (an Anti-HIV Drug) in HIV-Positive Women and to Compare Zidovudine Metabolism in Men and Women Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 The purpose of this study is to look at the effects of different methods of birth control (oral and injectable) on how the body absorbs, makes available, and removes zidovudine (ZDV). This study will also evaluate the differences in men and women in how the body absorbs, makes available, and removes ZDV. Past research has shown that the effectiveness of ZDV as an anti-HIV drug might be decreased in individuals who use certain methods of birth control. ZDV may also have different effects in men compared to women.
NCT00001202 Treatment of Boys With Precocious Puberty Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 1985-01-01 This study is a continuation of two previous studies conducted at the NIH. The first study , "Treatment of True Precocious Puberty with a Long-Acting Lutenizing Hormone Releasing Hormone Analog (D-Trp(6)-Pro(9)-Net-LHRH)" had less than optimal results. Some patients, all of whom were diagnosed with familial isosexual precocious puberty, had an inadequate response to the medication and were observed to have high levels of testosterone, advanced bone aging, and other complications of the disease. As a result these patients were enrolled in a second study In the second study, "Spironolactone Treatment for Boys with Familial Isosexual Precocious Puberty", - the patients received another medication, spironolactone (Aldactone). The drug blocked the effects of testosterone, -but bone age advancement did not improve. Some patients began experiencing gynecomastia (an abnormal growth of the male breasts). Researchers believe these may be the effects of elevated levels of estrodiol (a form of the female hormone, estrogen). In the present study, testolactone is added to the drug regimen to block the production of estrogen. The study therefore uses spironolactone to prevent the action of the male hormones (androgen) and testolactone to block the production of female hormones (estrogen). Deslorelin, an LHRH analog which works by turning off true (central) puberty, is added to the drug regimen once true puberty begins. This is because it is know that boys with familial male precocious puberty go into true puberty too early (despite treatment with spironolactone and testolactone), and when that happens, the spironolactone and testolactone are no longer as effective. The goal of the treatment is to delay sexual development until a more appropriate age and prevent short adult stature (height).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Depo-estradiol

Condition Name

Condition Name for Depo-estradiol
Intervention Trials
Infertility 83
Contraception 73
Menopause 54
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Condition MeSH

Condition MeSH for Depo-estradiol
Intervention Trials
Infertility 110
Breast Neoplasms 82
Syndrome 33
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Clinical Trial Locations for Depo-estradiol

Trials by Country

Trials by Country for Depo-estradiol
Location Trials
Germany 75
China 70
Canada 40
Egypt 38
United Kingdom 34
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Trials by US State

Trials by US State for Depo-estradiol
Location Trials
California 87
Florida 72
Texas 64
Pennsylvania 64
New York 61
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Clinical Trial Progress for Depo-estradiol

Clinical Trial Phase

Clinical Trial Phase for Depo-estradiol
Clinical Trial Phase Trials
Phase 4 162
Phase 3 188
Phase 2/Phase 3 26
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Clinical Trial Status

Clinical Trial Status for Depo-estradiol
Clinical Trial Phase Trials
Completed 422
Recruiting 165
Not yet recruiting 114
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Clinical Trial Sponsors for Depo-estradiol

Sponsor Name

Sponsor Name for Depo-estradiol
Sponsor Trials
Bayer 46
National Cancer Institute (NCI) 42
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 35
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Sponsor Type

Sponsor Type for Depo-estradiol
Sponsor Trials
Other 760
Industry 380
NIH 152
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