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Last Updated: May 27, 2022

CLINICAL TRIALS PROFILE FOR ESTRADIOL


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505(b)(2) Clinical Trials for 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 Completed Group Health Cooperative Phase 3 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 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 Estradiol

Condition Name

Condition Name for Estradiol
Intervention Trials
Infertility 89
Contraception 79
Breast Cancer 56
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Condition MeSH

Condition MeSH for Estradiol
Intervention Trials
Infertility 121
Breast Neoplasms 91
Syndrome 35
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Clinical Trial Locations for Estradiol

Trials by Country

Trials by Country for Estradiol
Location Trials
Germany 77
China 74
Canada 58
Poland 52
Egypt 51
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Trials by US State

Trials by US State for Estradiol
Location Trials
California 107
Florida 88
Texas 81
New York 76
Pennsylvania 75
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Clinical Trial Progress for Estradiol

Clinical Trial Phase

Clinical Trial Phase for Estradiol
Clinical Trial Phase Trials
Phase 4 184
Phase 3 200
Phase 2/Phase 3 22
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Clinical Trial Status

Clinical Trial Status for Estradiol
Clinical Trial Phase Trials
Completed 565
Recruiting 108
Unknown status 96
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Clinical Trial Sponsors for Estradiol

Sponsor Name

Sponsor Name for Estradiol
Sponsor Trials
National Cancer Institute (NCI) 48
Bayer 47
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 37
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Sponsor Type

Sponsor Type for Estradiol
Sponsor Trials
Other 876
Industry 428
NIH 170
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