Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors

Aarhus University Hospital Skejby

Status: Unknown

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT00317928

160350-1

Details and patient eligibility

About

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.

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnosis of PCOS
• Age 20 - 45

Exclusion Criteria:Diabetes

• Diabetes
• Hormonal treatment
• Pregnancy, lactation
• Periclimacteric

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind