| Trial ID: | L5244 |
| Source ID: | NCT00682890
|
| Associated Drug: |
Placebo
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| Title: |
Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00682890/results
|
| Conditions: |
Polycystic Ovary Syndrome|PCOS|Insulin Sensitivity
|
| Interventions: |
DRUG: placebo|DRUG: metformin
|
| Outcome Measures: |
Primary: Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI), 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)., baseline and 3 months|Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI), 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)., baseline and 3 months |
|
| Sponsor/Collaborators: |
Sponsor: Virginia Commonwealth University
|
| Gender: |
FEMALE
|
| Age: |
ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
28
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2005-11
|
| Completion Date: |
2010-01
|
| Results First Posted: |
2014-08-20
|
| Last Update Posted: |
2014-08-20
|
| Locations: |
General Clinical Research Center, Richmond, Virginia, 23298, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00682890
|
