Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy

This study has been completed.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00283816
First received: January 27, 2006
Last updated: July 19, 2011
Last verified: April 2011
Results First Received: April 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Polycystic Ovary Syndrome
Interventions: Drug: Metformin
Drug: Oral Contraceptive Pill
Behavioral: Lifestyle Management Program
Behavioral: Quality of Life Questionnaire
Procedure: Oral Glucose Tolerance Test
Procedure: Blood work
Procedure: Abdominal Ultra Sound
Procedure: Dual-energy x-ray absorptiometry (DEXA scan)
Drug: placebo

  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
No text entered.

Reporting Groups
  Description
Metformin Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
Placebo Subjects given a placebo in addition to oral contraceptive and lifestyle program

Participant Flow:   Overall Study
    Metformin     Placebo  
STARTED     18     18  
COMPLETED     16     16  
NOT COMPLETED     2     2  



  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.
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Reporting Groups
  Description
Metformin Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
Placebo Subjects given a placebo in addition to oral contraceptive and lifestyle program
Total Total of all reporting groups

Baseline Measures
    Metformin     Placebo     Total  
Number of Participants  
[units: participants]
  18     18     36  
Age  
[units: participants]
     
<=18 years     18     18     36  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  14.7  ± 1.6     15.8  ± 1.6     15.1  ± 1.6  
Gender  
[units: participants]
     
Female     18     18     36  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     18     18     36  



  Outcome Measures
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1.  Primary:   Reduction in Abdominal Fat as Measured by Waist Circumference.   [ Time Frame: baseline and 24 weeks ]

2.  Secondary:   Change in Weight Post Minus Pre Intervention.   [ Time Frame: baseline and 24 weeks ]

3.  Secondary:   Total Testosterone Change   [ Time Frame: baseline and 24 weeks ]

4.  Secondary:   Change in Sex Hormone Binding Globulin (SHBG)   [ Time Frame: baseline and 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Kathleen M. Hoeger, MD, MPH
Organization: University of Rochester Medical Center
phone: 585-275-7891
e-mail: Kathy_Hoeger@urmc.rochester.edu


No publications provided


Responsible Party: Kathleen Hoeger, MD, University of Rochester Medical Center
ClinicalTrials.gov Identifier: NCT00283816     History of Changes
Other Study ID Numbers: RSRB-00012501, GCRC#1083
Study First Received: January 27, 2006
Results First Received: April 8, 2011
Last Updated: July 19, 2011
Health Authority: United States: Food and Drug Administration