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

This study has been terminated.
(Lack of recruitment)
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00682890
First received: May 21, 2008
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Polycystic Ovary Syndrome
PCOS
Insulin Sensitivity
Drug: placebo
Drug: metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI) [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    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).


Enrollment: 28
Study Start Date: November 2005
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo tablet and birth control pill daily
Drug: placebo
placebo birth control pill daily
Active Comparator: 2
metformin 2000 mg and birth control pill daily
Drug: metformin
2000 mg per day for 3 months daily birth control pill

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682890

Locations
United States, Virginia
General Clinical Research Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Study Director: Leo Dunn, MD DSMB
  More Information

Additional Information:
Publications:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00682890     History of Changes
Other Study ID Numbers: R03HD47298
Study First Received: May 21, 2008
Results First Received: January 21, 2014
Last Updated: August 1, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disease
Pathologic Processes
Metformin
Contraceptives, Oral
Contraceptives, Oral, Combined
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014