Clinical Trial: Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Theca Cell Function in Women With Polycystic Ovary Syndrome

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 luteinizing hormone (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 human chorionic gonadotgropin (hCG), an LH surrogate, will be assessed in PCOS and normal women.

Detailed Summary: 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, 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 The total amount of blood withdrawn will be about 35 teaspoons.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.
Sponsor: University of California, San Diego

Current Primary Outcome: Serum 17OHP Responses to hCG [ Time Frame: 24 hrs post dose ]

Assess serum 17OHP levels following each dose of hCG adminstration in PCOS and normal subjects


Original Primary Outcome: Serum 17OHP Responses to hCG [ Time Frame: -0.5, 0, 0.5, 24 hrs ]

Current Secondary Outcome: Serum Testosterone Responses to hCG [ Time Frame: -0.5, 0, 0.5, 24 hrs ]

Original Secondary Outcome: Same as current

Information By: University of California, San Diego

Dates:
Date Received: September 4, 2008
Date Started: September 2007
Date Completion:
Last Updated: February 9, 2016
Last Verified: February 2016