search
Back to results

Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors

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 focused on measuring Polycystic Ovary Syndrome, Metformin, Metabolic Syndrome, Hyperandrogenism, Ovulation

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of PCOS Age 20 - 45 Exclusion Criteria:Diabetes Diabetes Hormonal treatment Pregnancy, lactation Periclimacteric

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 24, 2006
    Last Updated
    October 10, 2006
    Sponsor
    Aarhus University Hospital Skejby
    Collaborators
    Regional Hospital Holstebro, Aarhus University Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00317928
    Brief Title
    Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2001
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Aarhus University Hospital Skejby
    Collaborators
    Regional Hospital Holstebro, Aarhus University Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    Hypothesis: Metformin treatment normalises hormone values and metabolic parameters in women with PCOS. Ovulation is restored and bleeding periods become regular. Fifty women with PCOS (Rotterdam criteria) are randomised to either placebo or metformin for 6 months. After a wash-out period of 3 months, the opposite treatment is given for another 6 months. Measurements are performed before ech treatment period, every second month during treatment and after completing treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovary Syndrome
    Keywords
    Polycystic Ovary Syndrome, Metformin, Metabolic Syndrome, Hyperandrogenism, Ovulation

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Metformin

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of PCOS Age 20 - 45 Exclusion Criteria:Diabetes Diabetes Hormonal treatment Pregnancy, lactation Periclimacteric
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ditte Trolle, MD
    Organizational Affiliation
    Skejby University Hospital, Aarhus, Denmark
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors

    We'll reach out to this number within 24 hrs