Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00747617
Recruitment Status : Completed
First Posted : September 5, 2008
Results First Posted : January 29, 2013
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Jeffrey Chang, MD, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE September 4, 2008
First Posted Date  ICMJE September 5, 2008
Results First Submitted Date  ICMJE August 4, 2011
Results First Posted Date  ICMJE January 29, 2013
Last Update Posted Date November 21, 2018
Study Start Date  ICMJE September 2007
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2013)
Serum 17OHP Responses to hCG [ Time Frame: 24 hrs post dose ]
Assess serum 17OHP levels following each dose of hCG adminstration in PCOS and normal subjects
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2008)
Serum 17OHP Responses to hCG [ Time Frame: -0.5, 0, 0.5, 24 hrs ]
Change History Complete list of historical versions of study NCT00747617 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
Serum Testosterone Responses to hCG [ Time Frame: -0.5, 0, 24 hrs ]
Mean serum testosterone levels before and after hCG injection. Serum testosterone levels before (-0.5 and 0 hrs) were averaged to achieve a single value
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2008)
Serum Testosterone Responses to hCG [ Time Frame: -0.5, 0, 0.5, 24 hrs ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)
Official Title  ICMJE Theca Cell Function in Women With Polycystic Ovary Syndrome
Brief 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2013)
25
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2008)
24
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00747617
Other Study ID Numbers  ICMJE 060679
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jeffrey Chang, MD, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: R, Jeffrey Chang, M.D. UCSD SChool of Medicine
PRS Account University of California, San Diego
Verification Date October 2018

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