Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism

Sponsor

National Center for Research Resources (NCRR) (NIH)

Overall Status

Completed

CT.gov ID

NCT00004763

Collaborator

Baylor College of Medicine (Other)

Enrollment

Study Details

Study Description

Brief Summary

OBJECTIVES:

Evaluate the beneficial effects of leuprolide depot, oral contraceptive therapy, and leuprolide/oral contraceptive therapy in the management of patients with ovarian hyperandrogenism.

Condition or Disease	Intervention/Treatment	Phase
Hyperandrogenism	Drug: leuprolide Drug: Ethinyl estradiol/norethindrone	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 1993

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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