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Trial Outcomes & Findings for Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS) (NCT NCT00682890)

NCT ID: NCT00682890

Last Updated: 2014-08-20

Results Overview

Insulin sensitivity as measured by a combination of insulin sensitivity index (ISI) which should go up after 3 month treatment period to show improvement, and insulin sensitivity (SI) which should go down after 3 month treatment period to show improvement. Note that the ISI as developed by Matsuda and DeFronzo from a calculation based on results from a standard oral glucose tolerance test (OGTT) (doi: 10.2337/diacare.22.9.1462 Diabetes Care September 1999 vol. 22 no. 9 1462-1470) is recorded as units on an arbitrary scale. SI data is based on a calculation derived from analysis of results of frequently sampled intravenous glucose tolerance test (FSIVGTT) by Bergman et al (doi:10.1172/JCI112886/J Clin Invest. 1987;79(3):790-800) and is reported with units min-1/(µlU/L).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

28 participants

Primary outcome timeframe

baseline and 3 months

Results posted on

2014-08-20

Participant Flow

All recruitment and testing conducted at VCU General Clinical Research Center from August 2006 to December 2009

Following enrollment but prior to group assignment 5 subject were excluded based on screening results. Randomized remaining 23 subjects.

Participant milestones

Participant milestones
Measure
Placebo
Placebo tablet and birth control pill daily
Metformin
metformin 2000 mg and birth control pill daily
Overall Study
STARTED
12
11
Overall Study
COMPLETED
10
9
Overall Study
NOT COMPLETED
2
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Placebo
Placebo tablet and birth control pill daily
Metformin
metformin 2000 mg and birth control pill daily
Overall Study
Lost to Follow-up
1
1
Overall Study
subject moved away
0
1
Overall Study
heavy menstrual bleeding
1
0

Baseline Characteristics

Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo
n=10 Participants
Placebo tablet and birth control pill daily
Metformin
n=9 Participants
metformin 2000 mg and birth control pill daily
Total
n=19 Participants
Total of all reporting groups
Age, Continuous
24.3 years
STANDARD_DEVIATION 1.3 • n=5 Participants
26.6 years
STANDARD_DEVIATION 1.4 • n=7 Participants
25.5 years
STANDARD_DEVIATION 1.4 • n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
9 Participants
n=7 Participants
19 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Body Mass Index (BMI)
32.6 kg/m2
STANDARD_DEVIATION 2.3 • n=5 Participants
36.2 kg/m2
STANDARD_DEVIATION 2.5 • n=7 Participants
34.4 kg/m2
STANDARD_DEVIATION 2.4 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 3 months

Insulin sensitivity as measured by a combination of insulin sensitivity index (ISI) which should go up after 3 month treatment period to show improvement, and insulin sensitivity (SI) which should go down after 3 month treatment period to show improvement. Note that the ISI as developed by Matsuda and DeFronzo from a calculation based on results from a standard oral glucose tolerance test (OGTT) (doi: 10.2337/diacare.22.9.1462 Diabetes Care September 1999 vol. 22 no. 9 1462-1470) is recorded as units on an arbitrary scale. SI data is based on a calculation derived from analysis of results of frequently sampled intravenous glucose tolerance test (FSIVGTT) by Bergman et al (doi:10.1172/JCI112886/J Clin Invest. 1987;79(3):790-800) and is reported with units min-1/(µlU/L).

Outcome measures

Outcome measures
Measure
Placebo
n=10 Participants
Placebo tablet and birth control pill daily
Metformin
n=9 Participants
metformin 2000 mg and birth control pill daily
Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI)
ISI at month 3
4.4 units on a scale
Standard Deviation 0.96
5.9 units on a scale
Standard Deviation 1.0
Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI)
ISI at baseline
4.7 units on a scale
Standard Deviation 1.6
7.3 units on a scale
Standard Deviation 1.7
Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI)
ISI change vs baseline
-0.3 units on a scale
Standard Deviation 1.1
-1.4 units on a scale
Standard Deviation 1.2

PRIMARY outcome

Timeframe: baseline and 3 months

Insulin sensitivity as measured by a combination of insulin sensitivity index (ISI) which should go up after 3 month treatment period to show improvement, and insulin sensitivity (SI) which should go down after 3 month treatment period to show improvement. Note that the ISI as developed by Matsuda and DeFronzo from a calculation based on results from a standard oral glucose tolerance test (OGTT) (doi: 10.2337/diacare.22.9.1462 Diabetes Care September 1999 vol. 22 no. 9 1462-1470) is recorded as units on an arbitrary scale. SI data is based on a calculation derived from analysis of results of frequently sampled intravenous glucose tolerance test (FSIVGTT) by Bergman et al (doi:10.1172/JCI112886/J Clin Invest. 1987;79(3):790-800) and is reported with units min-1/(µlU/L).

Outcome measures

Outcome measures
Measure
Placebo
n=10 Participants
Placebo tablet and birth control pill daily
Metformin
n=9 Participants
metformin 2000 mg and birth control pill daily
Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI)
SI at baseline
2.26 min-1/(µlU/L)
Standard Deviation 0.48
3.83 min-1/(µlU/L)
Standard Deviation 0.78
Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI)
SI at 3 months
2.8 min-1/(µlU/L)
Standard Deviation 0.87
2.11 min-1/(µlU/L)
Standard Deviation 0.44
Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI)
SI change vs baseline
0.544 min-1/(µlU/L)
Standard Deviation 0.79
-1.72 min-1/(µlU/L)
Standard Deviation 0.61

Adverse Events

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Dr. John Nestler

Virginia Commonwealth University

Phone: 804-828-3389

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place