We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00283816
First Posted: January 30, 2006
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: Double (Participant, 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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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 Medical Center
phone: 585-275-7891
e-mail: Kathy_Hoeger@urmc.rochester.edu



Responsible Party: Kathleen M. Hoeger, MD, University of Rochester
ClinicalTrials.gov Identifier: NCT00283816     History of Changes
Other Study ID Numbers: RSRB-00012501
GCRC#1083
First Submitted: January 27, 2006
First Posted: January 30, 2006
Results First Submitted: April 8, 2011
Results First Posted: July 13, 2011
Last Update Posted: May 15, 2015