Trial Outcomes & Findings for Treatment of Adolescent Polycystic Ovary Syndrome (PCOS) (NCT NCT00714233)
NCT ID: NCT00714233
Last Updated: 2015-05-15
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
43 participants
Primary outcome timeframe
24 week
Results posted on
2015-05-15
Participant Flow
Participant milestones
| Measure |
Metformin
Randomized to Metformin 1700mg daily for 24 weeks
|
Oral Contraceptive
Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
|
Lifestyle Counseling
lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
|
Placebo to Metformin
randomized to placebo pill identical to active metformin arm
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
11
|
10
|
|
Overall Study
COMPLETED
|
6
|
10
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)
Baseline characteristics by cohort
| Measure |
Metformin
n=10 Participants
Randomized to Metformin 1700mg daily for 24 weeks
|
Oral Contraceptive
n=11 Participants
Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
|
Lifestyle Counseling
n=11 Participants
lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
|
Placebo to Metformin
n=10 Participants
randomized to placebo pill identical to active metformin arm
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
16 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
15.4 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
15.4 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
15.4 years
STANDARD_DEVIATION 1.7 • n=4 Participants
|
15.6 years
STANDARD_DEVIATION 1.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
11 participants
n=5 Participants
|
10 participants
n=4 Participants
|
42 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 weekPopulation: Analysis was a description of number of recruited subjects.
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
Outcome measures
| Measure |
Metformin
n=10 Participants
Randomized to Metformin 1700mg daily for 24 weeks
|
Oral Contraceptive
n=11 Participants
Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
|
Lifestyle Counseling
n=11 Participants
lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
|
Placebo to Metformin
n=10 Participants
randomized to placebo pill identical to active metformin arm
|
|---|---|---|---|---|
|
Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification
|
10 participants
|
11 participants
|
11 participants
|
10 participants
|
SECONDARY outcome
Timeframe: baseline and 24 weeksPopulation: Analysis per protocol
In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI
Outcome measures
| Measure |
Metformin
n=8 Participants
Randomized to Metformin 1700mg daily for 24 weeks
|
Oral Contraceptive
Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
|
Lifestyle Counseling
lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
|
Placebo to Metformin
randomized to placebo pill identical to active metformin arm
|
|---|---|---|---|---|
|
Weight Loss in Lifestyle Intervention Group
|
-1.1 kg/m^2
Standard Deviation 6.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 24 weeksPopulation: analysis per protocol
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.
Outcome measures
| Measure |
Metformin
n=6 Participants
Randomized to Metformin 1700mg daily for 24 weeks
|
Oral Contraceptive
n=10 Participants
Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
|
Lifestyle Counseling
n=8 Participants
lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
|
Placebo to Metformin
n=10 Participants
randomized to placebo pill identical to active metformin arm
|
|---|---|---|---|---|
|
Change in Free Androgen Index (FAI)
|
-0.1 total T/SHBG
Standard Deviation 3.2
|
-16.7 total T/SHBG
Standard Deviation 8
|
-13.7 total T/SHBG
Standard Deviation 10.9
|
1.2 total T/SHBG
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: baseline and 24 weeksMeasurement of SHBG by treatment group pre and post intervention
Outcome measures
| Measure |
Metformin
n=6 Participants
Randomized to Metformin 1700mg daily for 24 weeks
|
Oral Contraceptive
n=10 Participants
Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
|
Lifestyle Counseling
n=8 Participants
lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
|
Placebo to Metformin
n=10 Participants
randomized to placebo pill identical to active metformin arm
|
|---|---|---|---|---|
|
Change in SHBG
|
2.6 ratio
Standard Deviation 8.6
|
77 ratio
Standard Deviation 38.4
|
17.6 ratio
Standard Deviation 18.3
|
2 ratio
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: baseline and 24 weeksChange in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo
Outcome measures
| Measure |
Metformin
n=6 Participants
Randomized to Metformin 1700mg daily for 24 weeks
|
Oral Contraceptive
n=10 Participants
Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
|
Lifestyle Counseling
n=8 Participants
lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
|
Placebo to Metformin
n=10 Participants
randomized to placebo pill identical to active metformin arm
|
|---|---|---|---|---|
|
Triglyceride Concentration by Treatment Group
|
-22.3 mg/dL
Standard Deviation 24.1
|
4.6 mg/dL
Standard Deviation 41
|
2.2 mg/dL
Standard Deviation 36.4
|
-6.6 mg/dL
Standard Deviation 27.8
|
SECONDARY outcome
Timeframe: baseline and 24 weeksChange in fasting glucose concentration by treatment group pre to post intervention
Outcome measures
| Measure |
Metformin
n=6 Participants
Randomized to Metformin 1700mg daily for 24 weeks
|
Oral Contraceptive
n=10 Participants
Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
|
Lifestyle Counseling
n=8 Participants
lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
|
Placebo to Metformin
n=10 Participants
randomized to placebo pill identical to active metformin arm
|
|---|---|---|---|---|
|
Change in Fasting Glucose
|
-6.7 mg/dL
Standard Deviation 10.3
|
6.9 mg/dL
Standard Deviation 8.7
|
0.4 mg/dL
Standard Deviation 7.2
|
-1.1 mg/dL
Standard Deviation 7.2
|
Adverse Events
Metformin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral Contraceptive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lifestyle Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo to Metformin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place