CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 25 enrolled
Drug / intervention
recombinant human chorionic gonadotropindrug
Likely dose
recombinant human chorionic gonadotropin 250 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00747617
NCT00747617Phase 3Completed

Theca Cell Function in Women With Polycystic Ovary Syndrome

University of California, San Diego·interventional·Posted Sep 5, 2008·Updated Nov 21, 2018

In Brief

A Phase 3 clinical trial evaluating recombinant human chorionic gonadotropin for Polycystic Ovary Syndrome. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2008
Enrollment StartSep 1, 2007
Primary CompletionApr 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.8 years ago

Interventions

recombinant human chorionic gonadotropindrug

Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of human chorionic gonadotropin administered intravenously on 5 separate occasions.