Hyperandrogenism
Conditions
Keywords
endocrine disorders, hyperandrogenism, rare disease
Brief summary
OBJECTIVES: I. Evaluate the beneficial effects of leuprolide depot, oral contraceptive therapy, and leuprolide/oral contraceptive therapy in the management of patients with ovarian hyperandrogenism.
Detailed description
PROTOCOL OUTLINE: This is a randomized study. Patients are randomly assigned to a 6-month course of leuprolide versus ethinyl estradiol/norethindrone (Ovcon 35) versus leuprolide plus Ovcon 35. Leuprolide is administered intramuscularly in depot form every 28 days.
Interventions
DRUGleuprolide
Sponsors
Baylor College of Medicine
National Center for Research Resources (NCRR)
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
PROTOCOL ENTRY CRITERIA: Disease Characteristics * Ovarian hyperandrogenism with Lorenzo hirsutism score 7 to 20, with or without severe acne * Serum hormone levels: Follicle-stimulating hormone no greater than 40 mIU/mL Luteinizing hormone no greater than 40 mIU/mL Testosterone 60 to 200 ng/dL Dehydroepiandrosterone sulfate no greater than 430 micrograms/dL 17-hydroxyprogesterone no greater than 3.3 ng/mL in follicular phase Prolactin no greater than 18 ng/dL * No adrenal or ovarian tumors Prior/Concurrent Therapy * At least 6 months since exogenous steroids At least 48 hours since drugs other than acetaminophen, ibuprofen, and aspirin Patient Characteristics * No malignancy, including the following carcinomas: Breast Cervix Ovary Uterus No other serious illness No cigarette smokers No nursing women No pregnancy within 6 months prior to entry
Outcome results
None listed