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Pharmacogenetics of Metformin Action in PCOS

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00703508
First received: June 20, 2008
Last updated: June 9, 2017
Last verified: June 2017
Results First Received: January 5, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Polycystic Ovary Syndrome
Intervention: Drug: Metformin 500 mg tablet

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
55 subjects were enrolled, however some subjects failed to meet eligibility criteria resulting in 26 subjects initiating and completing all study phases.

Reporting Groups
  Description
Metformin

Metformin tablet, 500 mg/tablet, 2 tablets every twelve hours, 9 months duration

Metformin 500 mg tablet: Metformin 500 mg tablets; two tablets every 12 hours for 9 months


Participant Flow:   Overall Study
    Metformin
STARTED   26 
COMPLETED   26 
NOT COMPLETED   0 



  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
Metformin

Metformin tablet, 500 mg/tablet, 2 tablets every twelve hours, 9 months duration

Metformin 500 mg tablet: Metformin 500 mg tablets; two tablets every 12 hours for 9 months


Baseline Measures
   Metformin 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.9  (4.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      26 100.0% 
Male      0   0.0% 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 35.0  (7.6) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Responders/Non-responders for Each STK11 rs8111699 Genotype (C/G, C/C, G/G)   [ Time Frame: 9 months ]

2.  Primary:   Ovulation Rate Over Study Duration for STK11 Genotypes CC, CG and GG   [ Time Frame: 9 months ]

3.  Secondary:   Determine in Which Genotype(s) Frequency of Ovulation Correlates With Improvement in Reduction in Total Testosterone and Insulin Sensitivity as Measured by the Matsuda Index.   [ Time Frame: 9 months ]


  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
Interpretations of our findings are limited by our small sample size.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Kai Cheang
Organization: Virginia Commonwealth University
phone: (804) 828-2257
e-mail: kicheang@vcu.edu


Publications of Results:
Cheang KI, Bhavi Modi, Maria Shulleeta, William S. Evans, Lubna Pal, Jerome F. Strauss and John E. Nestler: Genetic Polymorphisms and Ovulatory Responsiveness to Metformin in Women with Polycystic Ovary Syndrome. Endo Reviews 36 (2): Supplement THR-109, Apr. 2015.


Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00703508     History of Changes
Other Study ID Numbers: HM11153
2U54HD034449 ( US NIH Grant/Contract Award Number )
Study First Received: June 20, 2008
Results First Received: January 5, 2017
Last Updated: June 9, 2017