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Efficacy of Metformin in Lean Women With Polycystic Ovary Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2006 by Aarhus University Hospital Skejby.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00319293
First Posted: April 27, 2006
Last Update Posted: October 11, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aarhus University Hospital
Information provided by:
Aarhus University Hospital Skejby
  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
Intervention Model: Parallel Assignment
Masking: Double
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

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319293


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

ClinicalTrials.gov Identifier: NCT00319293     History of Changes
Other Study ID Numbers: 160350-2
First Submitted: April 26, 2006
First Posted: April 27, 2006
Last Update Posted: October 11, 2006
Last Verified: October 2006

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