ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 30 for:    nichd Polycystic Ovary Syndrome (PCOS)

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

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.
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
Enrollment 114

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Metformin Placebo
Hide Arm/Group Description Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion Placebo (2 tablets twice a day) initiated in a step-up fashion
Period Title: Overall Study
Started 55 59
Completed 22 16
Not Completed 33 43
Reason Not Completed
Lost to Follow-up             15             19
Withdrawal by Subject             12             20
Adverse Event             6             0
Pregnancy             0             4
Arm/Group Title Metformin Placebo Total
Hide Arm/Group Description Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion Placebo (2 tablets twice a day) initiated in a step-up fashion Total of all reporting groups
Overall Number of Baseline Participants 55 59 114
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 59 participants 114 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 59 participants 114 participants
29  (4.5) 28.8  (4.6) 28.9  (4.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 59 participants 114 participants
Female
55
 100.0%
59
 100.0%
114
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants 59 participants 114 participants
55 59 114
1.Primary Outcome
Title Change in Testosterone After 6 Months of Treatment
Hide Description [Not Specified]
Time Frame baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:
Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
Placebo (2 tablets twice a day) initiated in a step-up fashion
Overall Number of Participants Analyzed 55 59
Least Squares Mean (95% Confidence Interval)
Unit of Measure: ng/dL
-2.1
(-12.1 to 7.9)
-6.4
(-16.9 to 4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Metformin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.3
Confidence Interval (2-Sided) 95%
-9.9 to 18.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Ovulation Rate
Hide Description Count of ovulations per subject during the treatment period.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
A total of 76 patients with daily urine collections.
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:
Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
Placebo (2 tablets twice a day) initiated in a step-up fashion
Overall Number of Participants Analyzed 37 39
Measure Type: Count of Participants
Unit of Measure: Participants
0 ovulations
10
  27.0%
19
  48.7%
1 ovulation
6
  16.2%
5
  12.8%
2 ovulations
4
  10.8%
7
  17.9%
3 ovulations
7
  18.9%
3
   7.7%
4 ovulations
4
  10.8%
2
   5.1%
5 ovulations
1
   2.7%
0
   0.0%
6+ ovulations
5
  13.5%
3
   7.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Metformin, Placebo
Comments This statistical analysis models the probability of ovulation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Zero-altered negative binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
0.9 to 6.6
Estimation Comments Placebo is the reference group, i.e. for the rate ratio, Metformin represents the numerator and Placebo the denominator.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Metformin, Placebo
Comments This statistical analysis models the count of ovulations provided a woman actually ovulated.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method Zero-altered negative binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter rate ratio
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.7 to 1.9
Estimation Comments Placebo is the reference group, i.e. for the rate ratio, Metformin represents the numerator and Placebo the denominator.
3.Secondary Outcome
Title Change in Insulin Sensitivity Index After 6 Months of Treatment
Hide Description [Not Specified]
Time Frame baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:
Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
Placebo (2 tablets twice a day) initiated in a step-up fashion
Overall Number of Participants Analyzed 55 59
Least Squares Mean (95% Confidence Interval)
Unit of Measure: index
1.9
(-1.0 to 4.8)
-2.7
(-6.2 to 0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Metformin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.6
Confidence Interval (2-Sided) 95%
0.1 to 9.0
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metformin Placebo
Hide Arm/Group Description Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion Placebo (2 tablets twice a day) initiated in a step-up fashion
All-Cause Mortality
Metformin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Metformin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/55 (0.00%)      0/59 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Metformin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/55 (69.09%)      33/59 (55.93%)    
Gastrointestinal disorders     
Diarrhea  19/55 (34.55%)  78 6/59 (10.17%)  22
stomach/abdominal pain or discomfort  6/55 (10.91%)  9 7/59 (11.86%)  16
nausea and/or vomiting  9/55 (16.36%)  27 7/59 (11.86%)  18
flatulence  2/55 (3.64%)  5 3/59 (5.08%)  3
flu  8/55 (14.55%)  12 4/59 (6.78%)  4
General disorders     
hair loss  3/55 (5.45%)  3 0/59 (0.00%)  0
allergic reaction  0/55 (0.00%)  0 3/59 (5.08%)  3
dental issues  3/55 (5.45%)  4 1/59 (1.69%)  2
Infections and infestations     
common cold/respiratory tract infection  12/55 (21.82%)  23 13/59 (22.03%)  19
Musculoskeletal and connective tissue disorders     
musculoskeletal  5/55 (9.09%)  7 9/59 (15.25%)  17
Nervous system disorders     
dizziness  3/55 (5.45%)  5 3/59 (5.08%)  3
headache/migraine  12/55 (21.82%)  42 11/59 (18.64%)  16
fatigue  2/55 (3.64%)  2 4/59 (6.78%)  4
altered mood/mood swings  0/55 (0.00%)  0 5/59 (8.47%)  6
Renal and urinary disorders     
bladder infection  1/55 (1.82%)  2 3/59 (5.08%)  9
Reproductive system and breast disorders     
dysmenorrhea/cramps  7/55 (12.73%)  14 9/59 (15.25%)  19
vaginal infection  3/55 (5.45%)  3 3/59 (5.08%)  3
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
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