Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors

Polycystic Ovary Syndrome Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00317928
• Other study ID #: 160350-1
• Status: Active, not recruiting
• Phase: N/A
• First received: April 24, 2006
• Last updated: October 10, 2006
• Start date: August 2001
• Est. completion date: September 2004

Study information

• Verified date: August 2001
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Diagnosis of PCOS

• Age 20 - 45

Exclusion Criteria:Diabetes

• Diabetes

• Hormonal treatment

• Pregnancy, lactation

• Periclimacteric

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Drug:
• Metformin

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Aarhus University Hospital, Regional Hospital Holstebro