Status:
WITHDRAWN
Effects of an Estrogen Replacement Therapy Skin Patch on Ovulation in Women With Premature Ovarian Failure
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Premature Ovarian Failure
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief Summary
This study will determine whether giving estrogen replacement therapy through an estradiol patch can improve ovulation rates in women with spontaneous premature ovarian failure. The ovaries are glands...
Detailed Description
Premature ovarian failure (POF) is a life altering and distressing diagnosis for women due to associated infertility. Despite having amenorrhea and markedly elevated serum gonadotropin levels, approxi...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients with karyotypically normal spontaneous premature ovarian failure (as defined by screening protocol 91-CH-0127), i.e. women who have at least 4 months of amenorrhea, two FSH levels above 40 mIU/mL, or in the menopausal range, at least one month apart, and a normal 46, XX karyotype, diagnosed with premature ovarian failure prior to the age of 40 who are between the age of 18 and 40 years will be candidates.
- Patients will be screened under the protocol 91-CH-0127 (Ovarian follicle function in patients with karyotypically normal spontaneous premature ovarian failure).
- EXCLUSION CRITERIA:
- General smokers (greater than 2 cigarettes/d), alcohol users (greater than 2 drinks/d), body mass index (BMI, kg/m(2) greater than or equal to 30 and less than or equal to 19, major dermatologic disorders, or a history of skin sensitivity to adhesive bandages, tape or transdermal matrix patches
- Hysterectomy
- Medication use current and/or past use of: diuretics, anticoagulants (heparin, coumadin), glucocorticoid drugs, gonadotropin-releasing hormone agonist or antagonist therapy, chemotherapy, use of other therapies to induce ovulation such as clomiphene citrate and other assisted reproductive technologies.(At present there are no proven ways to improve ovulation rate in these women)
- Medical history of anorexia nervosa, hyperprolactinemia, Cushing's syndrome, gastrectomy, osteogenesis imperfecta, mastocytosis, rheumatoid arthritis, long term parenteral nutrition, hemolytic anemia, hemochromatosis and thalassemia, ankylosing spondylitis, multiple myeloma, any cancer, any other major illness
- Contraindications to hormone replacement therapy thromboembolic event associated with previous estrogen use history of endometrial cancer or hyperplasia history of breast cancer
- hypertriglyceridemia (fasting triglyceride levels greater than 250 mg/dL) undiagnosed vaginal bleeding known sensitivity to agents.
- Active liver disease with more than 3 times elevation of liver enzymes.
Exclusion
Key Trial Info
Start Date :
August 25 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00370019
Start Date
August 25 2006
End Date
December 12 2011
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892