Status:
COMPLETED
Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)
Lead Sponsor:
University of California, San Diego
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-35 years
Phase:
PHASE3
Brief Summary
The mechanism for increased androgen production in women with polycystic ovary syndrome (PCOS) is not well understood. Excess androgen production by the ovary is stimulated by increased pituitary lute...
Detailed Description
Each subject (normal and PCOS women) will be admitted to the UCSD General Clinical Research Center (GCRC) for study on 5 occasions. All subjects will receive an intravenous injection of hCG dose of 1,...
Eligibility Criteria
Inclusion
- Normal CBC (Hemoglobin must be at least 11mg/dl)
- Normal renal and liver function tests
- Normal vital signs including normal blood pressure
Exclusion
- No oral contraceptives
- No insulin lowering drugs
- No anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)
- No medications that will influence androgen metabolism or clearance
- No medications that will inhibit the cytochrome P450 enzyme system (cimetidine, ketoconozole, etc)
- No use of clomiphene citrate within 3 months prior to study
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00747617
Start Date
September 1 2007
End Date
September 1 2010
Last Update
November 21 2018
Active Locations (1)
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1
University of California, San Diego, School of Medicine
La Jolla, California, United States, 92093