Efficacy of Metformin in Lean Women With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00319293
• Other study ID #: 160350-2
• Status: Not yet recruiting
• Phase: N/A
• First received: April 26, 2006
• Last updated: October 10, 2006

Study information

• Verified date: October 2006
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Insulin resistance is an important feature of the polycystic ovary syndrome,and patiens are successfully treated with the insulin sensitizing agent metformin. The insulin resistance of lean patients with the syndrome is debated. In this study, we will study the change in insulin resistance, metabolic and hormonal factors after 3 months of metformin treatment in lean PCOS women.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• PCOS (Rotterdam criteria)

• BMI < 27

• No medication for 3 months

Exclusion Criteria:

• Pregnancy

• Lactation

• Other endocrinologic disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel 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 (2)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Aarhus University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance
Primary	Hormonal factors
Primary	Metabolic factors