Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)
| Status: | Completed |
|---|---|
| Conditions: | Ovarian Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 11/23/2018 |
| Start Date: | September 2007 |
| End Date: | September 2010 |
Theca Cell Function in Women With Polycystic Ovary Syndrome
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.
(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.
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, 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 The total amount of blood withdrawn will be about 35 teaspoons.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.
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, 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.
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
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