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

• ClinicalTrials.gov Identifier: NCT00004763
• Recruitment Status: Completed
• First Posted: February 25, 2000
• Last Update Posted: June 24, 2005
• Sponsor: National Center for Research Resources (NCRR)
• Collaborator: Baylor College of Medicine
• Information provided by: Office of Rare Diseases (ORD)

Tracking Information

• First Submitted Date: February 24, 2000
• First Posted Date: February 25, 2000
• Last Update Posted Date: June 24, 2005
• Study Start Date: January 1993
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism
• Official Title: Not Provided

Brief 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Primary Purpose: Treatment
• Condition: Hyperandrogenism

Intervention

• Drug: leuprolide
• Drug: Ethinyl estradiol/norethindrone

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: June 23, 2005): 45
• Original Enrollment: Same as current
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 15 Years to 40 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00004763
• Other Study ID Numbers: 199/11717; BCM-11717
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: National Center for Research Resources (NCRR)
• Original Study Sponsor: Same as current
• Collaborators: Baylor College of Medicine

Investigators

• Study Chair: Karen E. Elkind-Hirsch; Baylor College of Medicine

• PRS Account: Office of Rare Diseases (ORD)
• Verification Date: December 2001