Trials / Completed

CompletedNCT00004763

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

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 45 (planned)

Sponsor: National Center for Research Resources (NCRR) · NIH
Sex: Female
Age: 15 Years – 40 Years
Healthy volunteers: Not accepted

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.

Conditions

Hyperandrogenism

Interventions

Type	Name	Description
DRUG	leuprolide
DRUG	Ethinyl estradiol/norethindrone

Timeline

Start date: 1993-01-01
First posted: 2000-02-25
Last updated: 2005-06-24

Source: ClinicalTrials.gov record NCT00004763. Inclusion in this directory is not an endorsement.