Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism
Overview
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.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Primary Purpose: Treatment
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
- Drug: leuprolide
- Drug: Ethinyl estradiol/norethindrone
Participating in This Clinical Trial
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
Gender Eligibility: Female
Minimum Age: 15 Years
Maximum Age: 40 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- National Center for Research Resources (NCRR)
- Collaborator
- Baylor College of Medicine
- Overall Official(s)
- Karen E. Elkind-Hirsch, Study Chair, Baylor College of Medicine
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.