Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism
I. Evaluate the beneficial effects of leuprolide depot, oral contraceptive therapy, and leuprolide/oral contraceptive therapy in the management of patients with ovarian hyperandrogenism.
Drug: Ethinyl estradiol/norethindrone
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||January 1993|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004763
|Study Chair:||Karen E. Elkind-Hirsch||Baylor College of Medicine|