Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors
This trial is active, not recruiting.
|Condition||polycystic ovary syndrome|
|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.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
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
|Principal investigator||Ditte Trolle, MD|
Call for more information