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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR ESTRADIOL ACETATE

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Clinical Trials for Estradiol Acetate

Trial ID Title Status Sponsor Phase Summary
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 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.
NCT00044837 Hormone Replacement Therapy and Anti-HIV Drugs in HIV-Infected, Postmenopausal Women Terminated National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 The purpose of this study is to find out if the anti-HIV drugs nelfinavir (NFV), lopinavir/ritonavir (LPV/r), and efavirenz (EFV) change the amount of estrogen in the blood when taken along with hormone replacement therapy (HRT) for menopause. HRT can be helpful for treating bothersome symptoms of menopause. However, it is not routinely used in HIV-infected postmenopausal women because it is not known how HRT interacts with anti-HIV drugs. The information obtained from this study will help doctors make recommendations for HRT in postmenopausal HIV-infected women.
NCT00089414 Treatment of Menstrually Related Disorders With Continuous v. Interrupted Oral Contraceptives Completed National Institute of Mental Health (NIMH) Phase 2 This study will determine whether uninterrupted treatment with birth control pills over several menstrual cycles prevents severe premenstrual syndrome (PMDD). Previous studies have shown that the hormones estrogen and progesterone regulate mood in women with MRMD. This study will use various treatment regimens with birth control pills and placebo (sugar pill) to clarify the relationships among estrogen and progesterone, the menstrual cycle, and mood. Healthy women between 18 and 45 years of age who menstruate may be eligible for this 15-week study. Candidates are screened with a physical examination, blood and urine tests, an electrocardiogram, and 3 months of symptoms ratings to confirm MRMD. Participants are randomly assigned to one of three treatment groups. Group 1 takes a birth control pill every day and on three occasions takes a placebo capsule. Group 2 takes a birth control pill most but not all days and on three occasions takes a placebo capsule. Group 3 takes a birth control pill every day and on three occasions takes another medication called CDB-2914 that causes menstrual bleeding to occur. Participants come to the NIH clinic every other week for blood tests and measurement of vital signs (blood pressure, pulse, and temperature) and to complete symptoms ratings scales. Subjects who develop breakthrough bleeding (menstruation earlier than expected) will have a transvaginal ultrasound. For this procedure, a probe is inserted into the vagina for about 10 minutes. The probe gives off and receives sound waves that can be used to form a picture of the endometrium (lining of the uterus).
NCT00127075 POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis Unknown status Hospices Civils de Lyon Phase 3 Multiple sclerosis (MS) affects 1 in 1000 people in western countries, mainly women in their childbearing years. It is an autoimmune disease of the central nervous system (CNS), which results in a chronic focal inflammatory response with subsequent demyelination and axonal loss. Recent prospective studies reported a significant decline by two-thirds in the rate of relapses during the third trimester of pregnancy and a significant increase by two-thirds during the first three months post-partum by comparison to the relapse rate observed during the year prior to the pregnancy (Confavreux et al., 1998). These dramatic changes in the relapse rate occur at a time when the impregnation of many substances (among which, sexual steroids) is at its highest, before a dramatic decline to the pre-pregnancy levels, immediately following delivery. It may be hypothesized that sexual steroids could exert beneficial effects through a modulation of the immune state with a lowering of the pro-inflammatory lymphocyte responses of the Th1 type and an enhancement of the anti-inflammatory responses of the Th2 type. They may also play a direct role in the remyelination of central nervous system lesions, as they do in the peripheral nervous system. The POPART'MUS study is a European, multicentre, randomized, placebo-controlled and double-blind clinical trial, which aims to prevent MS relapses related to the post-partum condition, by administering high doses of progestin (nomegestrol acetate), in combination with endometrial protective doses of estradiol. Treatment will be given immediately after delivery and continuously during the first three months post-partum. Assuming the results of the trial to be positive, this new treatment could be considered in the relapsing-remitting phase of the disease in women afar from pregnancy and post-partum.
NCT00163072 Pharmacokinetics and Safety of Transdermal Megestrol Acetate Withdrawn Milton S. Hershey Medical Center Phase 4 Rationale: Megestrol acetate (Megace®) is a progestin analog that is FDA approved for the palliative treatment of breast and endometrial carcinoma. It is also commonly used as an appetite stimulant, particularly in HIV and cancer patients with poor appetite from their primary disease and/or their therapy. Megace is well absorbed orally, however, many patients, particularly younger ones have difficulty taking oral medications. Transdermal progestins are available and are FDA approved. For example, Ortho EvraTM is a transdermal contraceptive patch containing an estrogen (ethinyl estradiol) and a progestin (norelgestromin). Key Objectives: Compare the pharmacokinetics of orally administered vs. transdermal Megace and determine if there are any local side effects of the transdermal route.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Estradiol Acetate

Condition Name

Condition Name for Estradiol Acetate
Intervention Trials
Contraception 10
Menopause 7
Heavy Menstrual Bleeding 7
Endometriosis 6
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Condition MeSH

Condition MeSH for Estradiol Acetate
Intervention Trials
Hemorrhage 11
Menorrhagia 9
Myofibroma 8
Leiomyoma 8
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Clinical Trial Locations for Estradiol Acetate

Trials by Country

Trials by Country for Estradiol Acetate
Location Trials
United States 258
Austria 6
Brazil 6
France 5
Canada 5
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Trials by US State

Trials by US State for Estradiol Acetate
Location Trials
Florida 18
California 14
Pennsylvania 13
Arizona 11
Washington 11
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Clinical Trial Progress for Estradiol Acetate

Clinical Trial Phase

Clinical Trial Phase for Estradiol Acetate
Clinical Trial Phase Trials
Phase 4 22
Phase 3 30
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Estradiol Acetate
Clinical Trial Phase Trials
Completed 44
Recruiting 16
Unknown status 9
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Clinical Trial Sponsors for Estradiol Acetate

Sponsor Name

Sponsor Name for Estradiol Acetate
Sponsor Trials
Merck Sharp & Dohme Corp. 11
AbbVie 6
Myovant Sciences GmbH 5
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Sponsor Type

Sponsor Type for Estradiol Acetate
Sponsor Trials
Other 58
Industry 50
NIH 10
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