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

Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperandrogenism

Intervention: leuprolide (Drug); Ethinyl estradiol/norethindrone (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Center for Research Resources (NCRR)

Official(s) and/or principal investigator(s):
Karen E. Elkind-Hirsch, Study Chair, Affiliation: Baylor College of Medicine

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.

Clinical Details

Study design: Allocation: Randomized, Primary Purpose: Treatment

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.

Eligibility

Minimum age: 15 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: January 1993
Last updated: June 23, 2005

Page last updated: August 23, 2015

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