NCT02984722UnknownNot Applicable
Extended-release vs Immediate-release Metformin in PCOS Women
Catholic University of the Sacred Heart1 site in 1 country80 target enrollmentStarted: December 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Gastro intestinal disorders
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Experimental
PCOS women treated with 1500 mg/die of extended-release metformin
Intervention: Metformin (Drug)
2
Experimental
PCOS women treated with 1500 mg/die of immediate-release metformin
Intervention: Metformin (Drug)
Outcomes
Primary Outcomes
Gastro intestinal disorders
Time Frame: 6 months
Secondary Outcomes
- testosterone levels(6 months)
- free androgen index(6 months)
- total cholesterol(6 months)
- dheas levels(6 months)
- tryglycerides levels(6 months)
- number of cycles in 6 months of therapy(6 months)
- insulin levels(6 months)
- hirsutism score(6 months)
- androstenedione levels(6 months)
- ovarian volume(6 months)
Investigators
Rosanna Apa
Professor
Catholic University of the Sacred Heart
Study Sites (1)
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