drugset / Trial / NCT00747617

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

NCT00747617

Phase 3 Completed 25 enrolled University of California, San Diego
Non-randomizedParallel-groupOpen-labelDiagnostic

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.

Timeline

Start
2007-09
Primary completion
2010-04
Completion
2010-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ovidrel Protein / enzyme biologic 1 ug
Comparator Ovidrel Protein / enzyme biologic 10 ug
Comparator Ovidrel Protein / enzyme biologic 25 ug
Comparator Ovidrel Protein / enzyme biologic 100 ug
Comparator Ovidrel Protein / enzyme biologic 250 ug