Phase 3
N=25
Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)
Polycystic Ovary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00747617 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Serum 17OHP Responses to hCG — 2.0; 1.2; 1.1; 1.0 ng/ml — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- recombinant human chorionic gonadotropin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Diego
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum 17OHP Responses to hCG |
2.0; 1.2; 1.1; 1.0; 2.7; 1.7 | <0.05 sig |
| SECONDARY Serum Testosterone Responses to hCG |
0.6; 0.3 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00747617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.