Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors
|ClinicalTrials.gov Identifier: NCT00317928|
Recruitment Status : Unknown
Verified August 2001 by Aarhus University Hospital Skejby.
Recruitment status was: Active, not recruiting
First Posted : April 25, 2006
Last Update Posted : October 11, 2006
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 or disease||Intervention/treatment|
|Polycystic Ovary Syndrome||Drug: Metformin|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Study Start Date :||August 2001|
|Estimated Study Completion Date :||September 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317928
|Principal Investigator:||Ditte Trolle, MD||Skejby University Hospital, Aarhus, Denmark|