Back to resultsCombination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)
Primary Purpose
Polycystic Ovary Syndrome, PCOS, Insulin Sensitivity
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
placebo
metformin
Sponsored by
About this trial
This is an interventional prevention trial for Polycystic Ovary Syndrome
Eligibility Criteria
Inclusion Criteria:
- Ages 18-45, , 8 menstrual cycles annually, elevated serum free testosterone, normal thyroid function test and serum prolactin, exclusion of late onset adrenal hyperplasia
Exclusion Criteria:
- Diabetes mellitus, pulmonary, cardiac, renal, hepatic, cholestatic, neurologic, psychiatric, infectious, malignant diseases,history of breast cancer, history of Deep Vein Thrombosis, pregnancy and lactation.
Sites / Locations
- General Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
1
2
Arm Description
Placebo tablet and birth control pill daily
metformin 2000 mg and birth control pill daily
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT00682890
First Posted
May 21, 2008
Last Updated
August 1, 2014
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT00682890
Brief Title
Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)
Official Title
Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this research study is to determine if adding Metformin, a drug that reduces insulin resistance, to birth control pills will reduce the risk of developing type 2 diabetes, high blood pressure. high lipid levels and heart disease in women with PCOS
Detailed Description
Inclusion criteria: PCOS women between the ages of 18-45,< 8 periods annually, elevated serum free testosterone, normal thyroid function tests and serum prolactin, exclusion of late onset adrenal hyperplasia, acceptable health based on interview and medical history, physical exam and lab tests, ability to comply with the requirements of the study and to provide signed, witnessed informed consent.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, PCOS, Insulin Sensitivity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo tablet and birth control pill daily
Arm Title
2
Arm Type
Active Comparator
Arm Description
metformin 2000 mg and birth control pill daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo birth control pill daily
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
2000 mg per day for 3 months daily birth control pill
Primary Outcome Measure Information:
Title
Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI)
Description
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).
Time Frame
baseline and 3 months
Title
Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI)
Description
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).
Time Frame
baseline and 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ages 18-45, , 8 menstrual cycles annually, elevated serum free testosterone, normal thyroid function test and serum prolactin, exclusion of late onset adrenal hyperplasia
Exclusion Criteria:
Diabetes mellitus, pulmonary, cardiac, renal, hepatic, cholestatic, neurologic, psychiatric, infectious, malignant diseases,history of breast cancer, history of Deep Vein Thrombosis, pregnancy and lactation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leo Dunn, MD
Organizational Affiliation
DSMB
Official's Role
Study Director
Facility Information:
Facility Name
General Clinical Research Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21733508
Citation
Essah PA, Arrowood JA, Cheang KI, Adawadkar SS, Stovall DW, Nestler JE. Effect of combined metformin and oral contraceptive therapy on metabolic factors and endothelial function in overweight and obese women with polycystic ovary syndrome. Fertil Steril. 2011 Aug;96(2):501-504.e2. doi: 10.1016/j.fertnstert.2011.05.091. Epub 2011 Jul 5.
Results Reference
result
Links:
URL
http://www.vcu.edu/pcos
Description
Related Info
Learn more about this trial
Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)
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