Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors

This study is ongoing, but not recruiting participants.

First Received: April 24, 2006 Last Updated: October 10, 2006 History of Changes

Sponsor:	Skejby Hospital
Collaborators:	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

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

Resource links provided by NLM:

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Skejby Hospital:

Polycystic Ovary Syndrome
Metformin
Metabolic Syndrome
Hyperandrogenism
Ovulation

Additional relevant MeSH terms:

Disease
Gonadal Disorders
Physiological Effects of Drugs
Metformin
Endocrine System Diseases
Ovarian Diseases
Cysts
Pharmacologic Actions

Adnexal Diseases
Genital Diseases, Female
Neoplasms
Hypoglycemic Agents
Pathologic Processes
Syndrome
Polycystic Ovary Syndrome
Ovarian Cysts

ClinicalTrials.gov processed this record on February 08, 2010