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Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2001 by Aarhus University Hospital Skejby.
Recruitment status was  Active, not recruiting
Regional Hospital Holstebro
Aarhus University Hospital
Information provided by:
Aarhus University Hospital Skejby Identifier:
First received: April 24, 2006
Last updated: October 10, 2006
Last verified: August 2001

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

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

Inclusion Criteria:

  • Diagnosis of PCOS
  • Age 20 - 45

Exclusion Criteria:Diabetes

  • Diabetes
  • Hormonal treatment
  • Pregnancy, lactation
  • Periclimacteric
  Contacts and Locations
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Please refer to this study by its identifier: NCT00317928

Sponsors and Collaborators
Aarhus University Hospital Skejby
Regional Hospital Holstebro
Aarhus University Hospital
Principal Investigator: Ditte Trolle, MD Skejby University Hospital, Aarhus, Denmark
  More Information Identifier: NCT00317928     History of Changes
Other Study ID Numbers: 160350-1 
Study First Received: April 24, 2006
Last Updated: October 10, 2006
Health Authority: Denmark: Ministry of Health

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

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 processed this record on October 25, 2016