A randomised study of the effect of metformin and exercise in overweight women with polycystic ovary syndrome - Metformin-exercise project
Phase 1
- Conditions
- Polycystic ovary syndrome is a condition characterized by obesity, anovulation and hyperandrogenism/hyperandrogenemia. Insulin resistance is common, and treatment is aimed at reducing this.
- Registration Number
- EUCTR2004-004257-26-DK
- Lead Sponsor
- Organisation name was not entered
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Polycystic ovary syndrome, BMI 30 - 35, age 25 - 35, no hormonal treatment, no diabetes, no contraindications to metformin treatment, not pregnant or breast-feeding, no physical problems making exercise impossible.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Hormonal treatment, diabetes, contraindications to metformin treatment, pregnant or breast-feeding, physical problems making exercise impossible, liver or renal disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect of medical treatment, i.e. metformin, with the effect of exercise on insulin resistance and quality of life.;Secondary Objective: Change in hormonal and metabolic factors. ;Primary end point(s): Change in insulin resistance and quality of life
- Secondary Outcome Measures
Name Time Method