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Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00714233
First Posted: July 14, 2008
Last Update Posted: May 15, 2015
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.
Information provided by (Responsible Party):
Kathleen M. Hoeger, MD, University of Rochester
Results First Submitted: April 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Polycystic Ovary Syndrome
Interventions: Drug: Metformin
Drug: Oral Contraceptive Pills (Yasmin)
Behavioral: Lifestyle Modification
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Metformin Randomized to Metformin 1700mg daily for 24 weeks
Oral Contraceptive Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
Lifestyle Counseling lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
Placebo to Metformin randomized to placebo pill identical to active metformin arm

Participant Flow:   Overall Study
    Metformin   Oral Contraceptive   Lifestyle Counseling   Placebo to Metformin
STARTED   10   11   11   10 
COMPLETED   6   10   10   6 
NOT COMPLETED   4   1   1   4 



  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 Randomized to Metformin 1700mg daily for 24 weeks
Oral Contraceptive Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
Lifestyle Counseling lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
Placebo to Metformin randomized to placebo pill identical to active metformin arm
Total Total of all reporting groups

Baseline Measures
   Metformin   Oral Contraceptive   Lifestyle Counseling   Placebo to Metformin   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   11   11   10   42 
Age 
[Units: Participants]
         
<=18 years   10   11   11   10   42 
Between 18 and 65 years   0   0   0   0   0 
>=65 years   0   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 16  (1.7)   15.4  (1.4)   15.4  (1.2)   15.4  (1.7)   15.6  (1.4) 
Gender 
[Units: Participants]
         
Female   10   11   11   10   42 
Male   0   0   0   0   0 
Region of Enrollment 
[Units: Participants]
         
United States   10   11   11   10   42 


  Outcome Measures
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1.  Primary:   Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification   [ Time Frame: 24 week ]

2.  Secondary:   Weight Loss in Lifestyle Intervention Group   [ Time Frame: baseline and 24 weeks ]

3.  Secondary:   Change in Free Androgen Index (FAI)   [ Time Frame: baseline and 24 weeks ]

4.  Secondary:   Change in SHBG   [ Time Frame: baseline and 24 weeks ]

5.  Secondary:   Triglyceride Concentration by Treatment Group   [ Time Frame: baseline and 24 weeks ]

6.  Secondary:   Change in Fasting Glucose   [ Time Frame: baseline and 24 weeks ]


  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:  
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: Kathleen M Hoeger MD MPH
Organization: University of Rochester
phone: 5852757891
e-mail: Kathy_hoeger@urmc.rochester.edu



Responsible Party: Kathleen M. Hoeger, MD, University of Rochester
ClinicalTrials.gov Identifier: NCT00714233     History of Changes
Other Study ID Numbers: RSRB # 09354
First Submitted: July 8, 2008
First Posted: July 14, 2008
Results First Submitted: April 8, 2011
Results First Posted: September 16, 2011
Last Update Posted: May 15, 2015