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

National Center for Research Resources (NCRR)45 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Hyperandrogenism

Interventions

leuprolideDRUG

Ethinyl estradiol/norethindroneDRUG

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.