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
Results First Received: August 4, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Polycystic Ovary Syndrome
Intervention: Drug: recombinant human chorionic gonadotropin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects recruited from UCSD clinics and coal advertising beginning in 2009 and ending in 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects involved women with PCOS and normal control women undergoing hCG stimulation

Reporting Groups
  Description
PCOS Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
Normal Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.

Participant Flow:   Overall Study
    PCOS     Normal  
STARTED     13     12  
COMPLETED     10     11  
NOT COMPLETED     3     1  
Lost to Follow-up                 3                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PCOS Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
Normal Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
Total Total of all reporting groups

Baseline Measures
    PCOS     Normal     Total  
Number of Participants  
[units: participants]
  13     12     25  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     13     12     25  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  28.5  ± 1.1     30  ± 1.3     29  ± 1.2  
Gender  
[units: participants]
     
Female     13     12     25  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     13     12     25  



  Outcome Measures

1.  Primary:   Serum 17OHP Responses to hCG   [ Time Frame: 24 hrs post dose ]

2.  Secondary:   Serum Testosterone Responses to hCG   [ Time Frame: -0.5, 0, 0.5, 24 hrs ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: R. Jeffrey Chang, M.D.
Organization: UCSD School of Medicine
phone: 858-534-8930
e-mail: rjchang@ucsd.edu


Publications:
Publications automatically indexed to this study:

Responsible Party: Jeffrey Chang, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00747617     History of Changes
Other Study ID Numbers: 060679
Study First Received: September 4, 2008
Results First Received: August 4, 2011
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration