Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Skejby Hospital Holstebro Hospital Aarhus University Hospital
Information provided by:	Skejby Hospital
ClinicalTrials.gov Identifier:	NCT00317928

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

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Further study details as provided by Skejby Hospital:

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

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317928

Sponsors and Collaborators

Skejby Hospital

Holstebro Hospital

Aarhus University Hospital

Investigators

Principal Investigator:

Ditte Trolle, MD

Skejby University Hospital, Aarhus, Denmark

More Information

Study ID Numbers:	160350-1
Study First Received:	April 24, 2006
Last Updated:	October 10, 2006
ClinicalTrials.gov Identifier:	NCT00317928
Health Authority:	Denmark: The Ministry of the Interior and Health

Keywords provided by Skejby Hospital:

Polycystic Ovary Syndrome
Metformin
Metabolic Syndrome
Hyperandrogenism
Ovulation

Study placed in the following topic categories:

Genital Diseases, Female
Gonadal Disorders
Metformin
Polycystic Ovary Syndrome
Endocrine System Diseases

Hyperandrogenism
Endocrinopathy
Ovarian Diseases
Cysts
Ovarian Cysts

Additional relevant MeSH terms:

Neoplasms
Hypoglycemic Agents
Pathologic Processes
Disease

Syndrome
Physiological Effects of Drugs
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009