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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00682890
• Other study ID #: R03HD047298
• Status: Terminated
• Phase: Phase 4
• First received: May 21, 2008
• Last updated: August 1, 2014
• Start date: November 2005
• Est. completion date: January 2010

Study information

• Verified date: August 2014
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Sensitivity
• PCOS
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• placebo
placebo birth control pill daily
• metformin
2000 mg per day for 3 months daily birth control pill

Locations

Country	Name	City	State
United States	General Clinical Research Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	No
Primary	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	No