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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeffrey Chang, MD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00747617
First received: September 4, 2008
Last updated: January 28, 2013
Last verified: January 2013

September 4, 2008
January 28, 2013
September 2007
April 2010   (final data collection date for primary outcome measure)
Serum 17OHP Responses to hCG [ Time Frame: 24 hrs post dose ] [ Designated as safety issue: No ]
Assess serum 17OHP levels following each dose of hCG adminstration in PCOS and normal subjects
Serum 17OHP responses to hCG [ Time Frame: -0.5, 0, 0.5, 24 hrs ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00747617 on ClinicalTrials.gov Archive Site
Serum Testosterone Responses to hCG [ Time Frame: -0.5, 0, 0.5, 24 hrs ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)
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.

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, 0.5,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 The total amount of blood withdrawn will be about 35 teaspoons.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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Polycystic Ovary Syndrome
Drug: recombinant human chorionic gonadotropin
Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of human chorionic gonadotropin administered intravenously on 5 separate occasions.
Other Name: Ovidrel
  • Active Comparator: PCOS group
    Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of recombinant human chorionic gonadotropin administered iv on 5 separate occasions.
    Intervention: Drug: recombinant human chorionic gonadotropin
  • Active Comparator: Control group
    Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of recombinant human chorionic gonadotropin administered iv on 5 separate occasions.
    Intervention: Drug: recombinant human chorionic gonadotropin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
September 2010
April 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00747617
060679
Yes
Jeffrey Chang, MD, University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: R, Jeffrey Chang, M.D. UCSD SChool of Medicine
University of California, San Diego
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP