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Efficacy of Metformin in Lean Women With Polycystic Ovary Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Aarhus University Hospital Skejby.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by:
Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT00319293
First received: April 26, 2006
Last updated: October 10, 2006
Last verified: October 2006
  Purpose

Insulin resistance is an important feature of the polycystic ovary syndrome,and patiens are successfully treated with the insulin sensitizing agent metformin. The insulin resistance of lean patients with the syndrome is debated. In this study, we will study the change in insulin resistance, metabolic and hormonal factors after 3 months of metformin treatment in lean PCOS women.


Condition Intervention
Polycystic Ovary Syndrome
Drug: Metformin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • Insulin resistance
  • Hormonal factors
  • Metabolic factors

Estimated Enrollment: 20
  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PCOS (Rotterdam criteria)
  • BMI < 27
  • No medication for 3 months

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • Other endocrinologic disease
  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: NCT00319293

Sponsors and Collaborators
Aarhus University Hospital Skejby
Aarhus University Hospital
Investigators
Principal Investigator: Birgitta Trolle, MD Skejby University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00319293     History of Changes
Other Study ID Numbers: 160350-2
Study First Received: April 26, 2006
Last Updated: October 10, 2006
Health Authority: Denmark: Ministry of Health

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

ClinicalTrials.gov processed this record on November 25, 2014