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

Completed · Phase 3

Conditions studied: Polycystic Ovary Syndrome

In brief

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.

Key facts

Study ID

NCT00747617

Run by

University of California, San Diego

People needed

25

Starts

2007-09-01

Expected to finish

2010-09-01

Last updated by the study team

2018-11-21

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Normal CBC (Hemoglobin must be at least 11mg/dl)
• Normal renal and liver function tests
• Normal vital signs including normal blood pressure

You may not qualify if…

• 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

Where it is running

• University of California, San Diego, School of Medicine — La Jolla, California, United States

Full record on ClinicalTrials.gov

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