Trial Outcomes & Findings for Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy (NCT NCT00283816)
NCT ID: NCT00283816
Last Updated: 2015-05-15
Results Overview
Change in waist circumference measured in cms used as a measure of abdominal adiposity, pre minus post intervention
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
36 participants
Primary outcome timeframe
baseline and 24 weeks
Results posted on
2015-05-15
Participant Flow
Participant milestones
| Measure |
Metformin
Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
|
Placebo
Subjects given a placebo in addition to oral contraceptive and lifestyle program
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy
Baseline characteristics by cohort
| Measure |
Metformin
n=18 Participants
Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
|
Placebo
n=18 Participants
Subjects given a placebo in addition to oral contraceptive and lifestyle program
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
14.7 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
15.8 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
15.1 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 24 weeksChange in waist circumference measured in cms used as a measure of abdominal adiposity, pre minus post intervention
Outcome measures
| Measure |
Metformin
n=16 Participants
2000mg of metformin in addition to oral contraceptive
|
Placebo
n=16 Participants
placebo pill in addition to oral contraceptive pill
|
|---|---|---|
|
Reduction in Abdominal Fat as Measured by Waist Circumference.
|
-3.9 cm
Standard Deviation 8.6
|
-1.4 cm
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: baseline and 24 weeksBody mass index change in adolescents enrolled in lifestyle intervention program
Outcome measures
| Measure |
Metformin
n=16 Participants
2000mg of metformin in addition to oral contraceptive
|
Placebo
n=16 Participants
placebo pill in addition to oral contraceptive pill
|
|---|---|---|
|
Change in Weight Post Minus Pre Intervention.
|
-1.9 kg/m^2
Standard Deviation 4.7
|
-1.2 kg/m^2
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: baseline and 24 weeksChange in total testosterone post minus pre intervention
Outcome measures
| Measure |
Metformin
n=16 Participants
2000mg of metformin in addition to oral contraceptive
|
Placebo
n=16 Participants
placebo pill in addition to oral contraceptive pill
|
|---|---|---|
|
Total Testosterone Change
|
-57.7 ng/dL
Standard Deviation 21.7
|
-27.6 ng/dL
Standard Deviation 30.1
|
SECONDARY outcome
Timeframe: baseline and 24 weeksSHBG concentration post minus pre-intervention
Outcome measures
| Measure |
Metformin
n=16 Participants
2000mg of metformin in addition to oral contraceptive
|
Placebo
n=16 Participants
placebo pill in addition to oral contraceptive pill
|
|---|---|---|
|
Change in Sex Hormone Binding Globulin (SHBG)
|
-73.4 nmol/L
Standard Deviation 31.9
|
-58 nmol/L
Standard Deviation 34.3
|
Adverse Events
Metformin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Kathleen M. Hoeger, MD, MPH
University of Rochester Medical Center
Phone: 585-275-7891
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place