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Theca Cell Function in Women With Polycystic Ovary Syndrome - NCT00747617-92093(Clinical Trial 240527)



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City:  La Jolla
State:  
CA
Zip Code: 92093
Conditions: Polycystic Ovary Syndrome
Purpose: The mechanism for increased androgen production in women with PCOS is not well understood. Excess androgn production by the ovary is stimulated by increased pituitary LH secretion in this disorder. The investigators hypothesize that in PCOS women ovarian theca cells, which are responsible for androgen synthesis, are more sensitive to LH stimulation compared to that of theca cells from normal women. To test this hypothesis, the investigators propose to conduct a dose-response study in which androgen responses to multiple doses of hCG, an LH surrogate, will be assessed in PCOS and normal women.
Study summary: Each subject (normal and PCOS women) will be admitted to the UCSD General Clinical Research Center for study on 5 occasions. All subjects will receive an intravenous injection of hCG dose of 1, 10, 25, 100, and 250 micrograms, each of which will be given on one of 5 different days each separated by at least two weeks at 8 AM. Blood samples will be obtained at t -0.5, 0, 0.5,and 24 hours after injection. All visits to the GCRC will be done as out patients. The total amount of blood withdrawn will be about 35 teaspoons. For normal control subjects this will be over a period of about 4-6 months and for PCOS subjects this will be over a period of about 6-10 weeks.
Criteria: Inclusion Criteria: - Normal CBC (Hemoglobin must be at least 11mg/dl) - Normal renal and liver function tests - Normal vital signs including normal blood pressure Exclusion Criteria: - 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
Study is available at: University of California, San Diego, School of Medicine
La Jolla, CA 92093
United States

Primary Contact:
Annette Haggan, R.N.
Email: aramoshaggan@ucsd.edu
Phone: 858-534-8972

Secondary Contact:
Annette Haggan, R.N.
Email: aramoshaggan@ucsd.edu
Phone: 858-534-8972
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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