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

This study has been terminated.
(Lack of recruitment)
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00682890
First received: May 21, 2008
Last updated: October 28, 2012
Last verified: October 2012
  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
PCOS
Insulin Sensitivity
Cardiovascular Inflammatory Markers
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 PCOS

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Improved insulin sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: November 2005
Study Completion Date: March 2009
Primary Completion Date: December 2008 (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 DVT, 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
Investigators
Study Director: Leo Dunn, MD DSMB
  More Information

Additional Information:
No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00682890     History of Changes
Other Study ID Numbers: R03HD47298
Study First Received: May 21, 2008
Last Updated: October 28, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 10, 2014