Efficacy of Metformin in Lean Women With Polycystic Ovary Syndrome

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. Identifier: NCT00319293
Recruitment Status : Unknown
Verified October 2006 by Aarhus University Hospital Skejby.
Recruitment status was:  Not yet recruiting
First Posted : April 27, 2006
Last Update Posted : October 11, 2006
Aarhus University Hospital
Information provided by:
Aarhus University Hospital Skejby

Brief Summary:
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 or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

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Primary Outcome Measures :
  1. Insulin resistance
  2. Hormonal factors
  3. Metabolic factors

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • Other endocrinologic disease

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 identifier (NCT number): NCT00319293

Sponsors and Collaborators
Aarhus University Hospital Skejby
Aarhus University Hospital
Principal Investigator: Birgitta Trolle, MD Skejby University Hospital Identifier: NCT00319293     History of Changes
Other Study ID Numbers: 160350-2
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: October 11, 2006
Last Verified: October 2006

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