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Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors

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 August 2001 by Aarhus University Hospital Skejby.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00317928
First Posted: April 25, 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.
Collaborators:
Regional Hospital Holstebro
Aarhus University Hospital
Information provided by:
Aarhus University Hospital Skejby
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome Drug: Metformin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital Skejby:

Estimated Enrollment: 50
Study Start Date: August 2001
Estimated Study Completion Date: September 2004
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of PCOS
  • Age 20 - 45

Exclusion Criteria:Diabetes

  • Diabetes
  • Hormonal treatment
  • Pregnancy, lactation
  • Periclimacteric
  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): NCT00317928


Sponsors and Collaborators
Aarhus University Hospital Skejby
Regional Hospital Holstebro
Aarhus University Hospital
Investigators
Principal Investigator: Ditte Trolle, MD Skejby University Hospital, Aarhus, Denmark
  More Information

ClinicalTrials.gov Identifier: NCT00317928     History of Changes
Other Study ID Numbers: 160350-1
First Submitted: April 24, 2006
First Posted: April 25, 2006
Last Update Posted: October 11, 2006
Last Verified: August 2001

Keywords provided by Aarhus University Hospital Skejby:
Polycystic Ovary Syndrome
Metformin
Metabolic Syndrome
Hyperandrogenism
Ovulation

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