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NCT00004763 Clinical Trial

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

Hyperandrogenism Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004763
Other study ID # 199/11717
Secondary ID BCM-11717
Status Completed
Phase Phase 2
First received February 24, 2000
Last updated June 23, 2005
Start date January 1993

Study information
Verified date December 2001
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• leuprolide

• Ethinyl estradiol/norethindrone

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Baylor College of Medicine
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