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
|
