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

NCT00682890 | Terminated Phase 4 Results DMC

• 1 other identifier: R03HD047298
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Polycystic Ovary Syndrome; PCOS; Insulin Sensitivity

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo tablet and birth control pill daily

Drug: placebo

2

ACTIVE COMPARATOR

metformin 2000 mg and birth control pill daily

Drug: metformin

Interventions

placebo DRUG

placebo birth control pill daily

1

metformin DRUG

2000 mg per day for 3 months daily birth control pill

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Diabetes mellitus, pulmonary, cardiac, renal, hepatic, cholestatic, neurologic, psychiatric, infectious, malignant diseases,history of breast cancer, history of Deep Vein Thrombosis, pregnancy and lactation.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

General Clinical Research Center

Richmond, Virginia, 23298, United States

Location

Related 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. 2011 Aug;96(2):501-504.e2. doi: 10.1016/j.fertnstert.2011.05.091. Epub 2011 Jul 5.

  PMID: 21733508 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Limitations and Caveats

study duration was relatively brief,earlier serum markers of the inflammatory process,e.g.,IL-6, were not evaluated,sample size planned was not achieved despite intensive recruitment efforts.

Results Point of Contact

• Title: Dr. John Nestler
• Organization: Virginia Commonwealth University

jnestler@mcvh-vcu.edu

804-828-3389

Study Officials

• Leo Dunn, MD

  DSMB

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: November 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: August 20, 2014
• Results First Posted: August 20, 2014

Record last verified: 2014-08

Locations

US (1)