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Trial record 10 of 31 for:    nichd Polycystic Ovary Syndrome (PCOS)

Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)

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ClinicalTrials.gov Identifier: NCT00151411
Recruitment Status : Completed
First Posted : September 9, 2005
Results First Posted : November 8, 2011
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center

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: Placebo
Behavioral: Lifestyle Intervention

  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 Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
Placebo Placebo (2 tablets twice a day) initiated in a step-up fashion

Participant Flow:   Overall Study
    Metformin   Placebo
STARTED   55   59 
COMPLETED   22   16 
NOT COMPLETED   33   43 
Lost to Follow-up                15                19 
Withdrawal by Subject                12                20 
Adverse Event                6                0 
Pregnancy                0                4 



  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 Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
Placebo Placebo (2 tablets twice a day) initiated in a step-up fashion
Total Total of all reporting groups

Baseline Measures
   Metformin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 55   59   114 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      55 100.0%      59 100.0%      114 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 29  (4.5)   28.8  (4.6)   28.9  (4.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      55 100.0%      59 100.0%      114 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   55   59   114 


  Outcome Measures

1.  Primary:   Change in Testosterone After 6 Months of Treatment   [ Time Frame: baseline and 6 months ]

2.  Secondary:   Ovulation Rate   [ Time Frame: 6 months ]

3.  Secondary:   Change in Insulin Sensitivity Index After 6 Months of Treatment   [ Time Frame: baseline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  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

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: Sandy Eyer
Organization: Penn State Hershey
phone: 717-531-1540
e-mail: seyer@hmc.psu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Richard S. Legro, M.D., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00151411     History of Changes
Other Study ID Numbers: 2003-172
HD-02-012
First Submitted: September 8, 2005
First Posted: September 9, 2005
Results First Submitted: June 7, 2011
Results First Posted: November 8, 2011
Last Update Posted: March 21, 2018