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Last Updated: February 25, 2021

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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 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.
OTC NCT02516202 The Vaginal Health Trial Recruiting Kaiser Permanente 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 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).
NCT00001221 Effect of Biosynthetic Growth Hormone and/or Ethinyl Estradiol on Adult Height in Patients With Turner Syndrome Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 1987-09-01 Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Girls with Turner syndrome are very short as children and as adults. Although their growth hormone secretion is almost always normal, giving injections of growth hormone to Turner syndrome girls may increase their rate of growth. In addition, most girls with Turner syndrome do not have normal ovaries. In normal girls the ovaries begin producing small amounts of the female sex hormone, estrogen at about 11 - 12 years of age. As girls grow older the level of estrogen increases. Estrogen is responsible for the changes in girls known as feminization. During feminization the hips grow wider, the breasts develop, there is an increase in the rate of growth, and eventually girls experience their first menstrual period. This study was designed to evaluate the effect of low dose estrogen, growth hormone, and the combination of low dose estrogen and growth hormone on adult height in girls with Turner syndrome. Patients will be entered into the study from ages 5 to 12 and will be randomly placed into one of four groups. 1. Group one will receive low dose estrogen 2. Group two will receive growth hormone 3. Group three will receive both low dose estrogen and growth hormone 4. Group four will receive a placebo "sugar pill" Once started, the treatment will continue until the patients approach their adult height, and growth slows to less than 1/2 inch over the preceding year. This usually occurs by the age of 15 or 16. Patients will be seen at the outpatient clinic every 6 months during the study and will receive a routine check-up with blood and urine tests, and hand/wrist X-rays to determine bone age. On patient's yearly visits they will have the density of bone measured in their spine and forearm.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Estradiol

Condition Name

Condition Name for Estradiol
Intervention Trials
Infertility 85
Contraception 74
Menopause 54
Breast Cancer 51
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Condition MeSH

Condition MeSH for Estradiol
Intervention Trials
Infertility 113
Breast Neoplasms 82
Syndrome 33
Polycystic Ovary Syndrome 31
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Clinical Trial Locations for Estradiol

Trials by Country

Trials by Country for Estradiol
Location Trials
Germany 75
China 70
Egypt 40
Canada 40
United Kingdom 34
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Trials by US State

Trials by US State for Estradiol
Location Trials
California 88
Florida 73
Pennsylvania 64
Texas 64
New York 61
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Clinical Trial Progress for Estradiol

Clinical Trial Phase

Clinical Trial Phase for Estradiol
Clinical Trial Phase Trials
Phase 4 165
Phase 3 189
Phase 2/Phase 3 26
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Clinical Trial Status

Clinical Trial Status for Estradiol
Clinical Trial Phase Trials
Completed 424
Recruiting 168
Not yet recruiting 118
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Clinical Trial Sponsors for Estradiol

Sponsor Name

Sponsor Name for 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 Estradiol
Sponsor Trials
Other 766
Industry 387
NIH 153
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