This trial is active, not recruiting.

Condition polycystic ovary syndrome
Treatment metformin
Sponsor Aarhus University Hospital Skejby
Collaborator Regional Hospital Holstebro
Start date August 2001
End date September 2004
Trial size 50 participants
Trial identifier NCT00317928, 160350-1


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double-blind
Primary purpose treatment

Eligibility Criteria

Female participants from 20 years up to 45 years old.

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

Additional Information

Principal investigator Ditte Trolle, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2006.
Information provided to ClinicalTrials.gov by Aarhus University Hospital Skejby.