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Efficacy of Metformin in Lean Women With Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Metformin
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: PCOS (Rotterdam criteria) BMI < 27 No medication for 3 months Exclusion Criteria: Pregnancy Lactation Other endocrinologic disease

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Insulin resistance
    Hormonal factors
    Metabolic factors

    Secondary Outcome Measures

    Full Information

    First Posted
    April 26, 2006
    Last Updated
    October 10, 2006
    Sponsor
    Aarhus University Hospital Skejby
    Collaborators
    Aarhus University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00319293
    Brief Title
    Efficacy of Metformin in Lean Women With Polycystic Ovary Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2006
    Overall Recruitment Status
    Unknown status
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Aarhus University Hospital Skejby
    Collaborators
    Aarhus University Hospital

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovary Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    20 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Primary Outcome Measure Information:
    Title
    Insulin resistance
    Title
    Hormonal factors
    Title
    Metabolic factors

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: PCOS (Rotterdam criteria) BMI < 27 No medication for 3 months Exclusion Criteria: Pregnancy Lactation Other endocrinologic disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Birgitta Trolle, MD
    Organizational Affiliation
    Skejby University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Metformin in Lean Women With Polycystic Ovary Syndrome

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