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Trial record 69 of 562 for:    "Polycystic Ovary Syndrome"

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

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ClinicalTrials.gov Identifier: NCT00283816
Recruitment Status : Completed
First Posted : January 30, 2006
Results First Posted : July 13, 2011
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
Kathleen M. Hoeger, MD, University of Rochester

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
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Metformin Placebo
Hide Arm/Group Description Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program Subjects given a placebo in addition to oral contraceptive and lifestyle program
Period Title: Overall Study
Started 18 18
Completed 16 16
Not Completed 2 2
Arm/Group Title Metformin Placebo Total
Hide Arm/Group Description Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program Subjects given a placebo in addition to oral contraceptive and lifestyle program Total of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
<=18 years
18
 100.0%
18
 100.0%
36
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
14.7  (1.6) 15.8  (1.6) 15.1  (1.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
18
 100.0%
18
 100.0%
36
 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 18 participants 18 participants 36 participants
18 18 36
1.Primary Outcome
Title Reduction in Abdominal Fat as Measured by Waist Circumference.
Hide Description Change in waist circumference measured in cms used as a measure of abdominal adiposity, pre minus post intervention
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:
2000mg of metformin in addition to oral contraceptive
placebo pill in addition to oral contraceptive pill
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: cm
-3.9  (8.6) -1.4  (10.9)
2.Secondary Outcome
Title Change in Weight Post Minus Pre Intervention.
Hide Description Body mass index change in adolescents enrolled in lifestyle intervention program
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:
metformin 2000mg in addition to oral contraceptive
placebo pill in addition to oral contraceptive
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: kg/m^2
-1.9  (4.7) -1.2  (4.5)
3.Secondary Outcome
Title Total Testosterone Change
Hide Description Change in total testosterone post minus pre intervention
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:
2000mg of metformin in addition to oral contraceptive
placebo pill in addition to oral contraceptive pill
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: ng/dL
-57.7  (21.7) -27.6  (30.1)
4.Secondary Outcome
Title Change in Sex Hormone Binding Globulin (SHBG)
Hide Description SHBG concentration post minus pre-intervention
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:
2000mg of metformin in addition to oral contraceptive
placebo pill in addition to oral contraceptive pill
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: nmol/L
-73.4  (31.9) -58  (34.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metformin Placebo
Hide Arm/Group Description Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program Subjects given a placebo in addition to oral contraceptive and lifestyle program
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 (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Metformin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
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
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