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Trial record 52 of 53 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND containing
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Treatment of Adolescent 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: NCT00714233
Recruitment Status : Completed
First Posted : July 14, 2008
Results First Posted : September 16, 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: 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
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Metformin Oral Contraceptive Lifestyle Counseling Placebo to Metformin
Hide Arm/Group Description Randomized to Metformin 1700mg daily for 24 weeks Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly randomized to placebo pill identical to active metformin arm
Period Title: Overall Study
Started 10 11 11 10
Completed 6 10 10 6
Not Completed 4 1 1 4
Arm/Group Title Metformin Oral Contraceptive Lifestyle Counseling Placebo to Metformin Total
Hide Arm/Group Description Randomized to Metformin 1700mg daily for 24 weeks Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly randomized to placebo pill identical to active metformin arm Total of all reporting groups
Overall Number of Baseline Participants 10 11 11 10 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 11 participants 10 participants 42 participants
<=18 years
10
 100.0%
11
 100.0%
11
 100.0%
10
 100.0%
42
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 11 participants 11 participants 10 participants 42 participants
16  (1.7) 15.4  (1.4) 15.4  (1.2) 15.4  (1.7) 15.6  (1.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 11 participants 10 participants 42 participants
Female
10
 100.0%
11
 100.0%
11
 100.0%
10
 100.0%
42
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 11 participants 11 participants 10 participants 42 participants
10 11 11 10 42
1.Primary Outcome
Title Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification
Hide Description The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY
Time Frame 24 week
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was a description of number of recruited subjects.
Arm/Group Title Metformin Oral Contraceptive Lifestyle Counseling Placebo to Metformin
Hide Arm/Group Description:
Randomized to Metformin 1700mg daily for 24 weeks
Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
randomized to placebo pill identical to active metformin arm
Overall Number of Participants Analyzed 10 11 11 10
Measure Type: Number
Unit of Measure: participants
10 11 11 10
2.Secondary Outcome
Title Weight Loss in Lifestyle Intervention Group
Hide Description In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis per protocol
Arm/Group Title Lifestyle Program
Hide Arm/Group Description:
Subjects enrolled in a nutrition and exercise program
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: kg/m^2
-1.1  (6.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Program
Comments Paired t-test to analyze BMI at baseline and 24 weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change in Free Androgen Index (FAI)
Hide Description Secondary measures of reduction in androgen measures of the different treatment arms. This is a ratio of total testosterone to sex hormone binding globulin (SHBG). The lower values correlate with lower amount of free testosterone. FAI <4 is consistent with a normal range.
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
analysis per protocol
Arm/Group Title Metformin Oral Contraceptive Lifestle Placebo to Metformin
Hide Arm/Group Description:
Group assigned to metformin with free androgen index measured
group assigned to oral contraceptive for 24 weeks
Those assigned to a nutrition and exercise program
Matched to metformin pill
Overall Number of Participants Analyzed 6 10 8 10
Mean (Standard Deviation)
Unit of Measure: total T/SHBG
-0.1  (3.2) -16.7  (8) -13.7  (10.9) 1.2  (12.3)
4.Secondary Outcome
Title Change in SHBG
Hide Description Measurement of SHBG by treatment group pre and post intervention
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Oral Contraceptive Lifestyle Counseling Placebo to Metformin
Hide Arm/Group Description:
Randomized to Metformin 1700mg daily for 24 weeks
Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
randomized to placebo pill identical to active metformin arm
Overall Number of Participants Analyzed 6 10 8 10
Mean (Standard Deviation)
Unit of Measure: ratio
2.6  (8.6) 77  (38.4) 17.6  (18.3) 2  (8.4)
5.Secondary Outcome
Title Triglyceride Concentration by Treatment Group
Hide Description Change in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Oral Contraceptive Lifestyle Counseling Placebo to Metformin
Hide Arm/Group Description:
Randomized to Metformin 1700mg daily for 24 weeks
Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
randomized to placebo pill identical to active metformin arm
Overall Number of Participants Analyzed 6 10 8 10
Mean (Standard Deviation)
Unit of Measure: mg/dL
-22.3  (24.1) 4.6  (41) 2.2  (36.4) -6.6  (27.8)
6.Secondary Outcome
Title Change in Fasting Glucose
Hide Description Change in fasting glucose concentration by treatment group pre to post intervention
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Oral Contraceptive Lifestyle Counseling Placebo to Metformin
Hide Arm/Group Description:
Randomized to Metformin 1700mg daily for 24 weeks
Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
randomized to placebo pill identical to active metformin arm
Overall Number of Participants Analyzed 6 10 8 10
Mean (Standard Deviation)
Unit of Measure: mg/dL
-6.7  (10.3) 6.9  (8.7) 0.4  (7.2) -1.1  (7.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metformin Oral Contraceptive Lifestyle Counseling Placebo to Metformin
Hide Arm/Group Description Randomized to Metformin 1700mg daily for 24 weeks Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly randomized to placebo pill identical to active metformin arm
All-Cause Mortality
Metformin Oral Contraceptive Lifestyle Counseling Placebo to Metformin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Metformin Oral Contraceptive Lifestyle Counseling Placebo to Metformin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/11 (0.00%)   0/11 (0.00%)   0/10 (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 Oral Contraceptive Lifestyle Counseling Placebo to Metformin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/11 (0.00%)   0/11 (0.00%)   0/10 (0.00%) 
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Kathleen M Hoeger MD MPH
Organization: University of Rochester
Phone: 5852757891
EMail: Kathy_hoeger@urmc.rochester.edu
Layout table for additonal information
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