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 free androgen index 6 months total cholesterol 6 months dheas levels 6 months number of cycles in 6 months of therapy 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms differentiate extended-release and immediate-release metformin in PCOS treatment?
How does extended-release metformin compare to immediate-release in improving insulin resistance and menstrual regularity in PCOS?
Which biomarkers correlate with gastrointestinal tolerability of extended-release vs immediate-release metformin in PCOS patients?
What adverse event profiles distinguish extended-release and immediate-release metformin formulations in PCOS management?
Are there combination therapies or alternative drug classes synergistic with metformin for PCOS metabolic and endocrine outcomes?
Trial Locations
- Locations (1)
Catholic university of Sacred Heart
🇮🇹Rome, Italy
Catholic university of Sacred Heart🇮🇹Rome, Italy