Extended-release vs Immediate-release Metformin in PCOS Women
- Registration Number
- NCT02984722
- Lead Sponsor
- Catholic University of the Sacred Heart
- Brief Summary
The aim of our study is to compare the different effects of 6 months treatment with extended-release metformin and immediate-release metformin on clinical, endocrine and metabolic parameters in women affected by polycystic ovary syndrome. We also evaluate gastrointestinal disorders associated with the two different compouds.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
- women with PCOS in accordance with Rotterdam criteria
Exclusion Criteria
- pregnancy
- diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
- past history of cardiovascular diseases
- past history of gastro-intestinal diseases
- significant liver or renal dysfunction (hypothalamic, pituitary, thiroidal or adrenal);
- neoplasms.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Metformin PCOS women treated with 1500 mg/die of extended-release metformin 2 Metformin PCOS women treated with 1500 mg/die of immediate-release metformin
- Primary Outcome Measures
Name Time Method Gastro intestinal disorders 6 months
- Secondary Outcome Measures
Name Time Method number of cycles in 6 months of therapy 6 months free androgen index 6 months total cholesterol 6 months dheas levels 6 months testosterone levels 6 months tryglycerides levels 6 months insulin levels 6 months hirsutism score 6 months androstenedione levels 6 months ovarian volume 6 months
Trial Locations
- Locations (1)
Catholic university of Sacred Heart
🇮🇹Rome, Italy