Polycystic Ovary Syndrome
Conditions
Keywords
PCOS, metformin
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.
Interventions
DRUGMetformin
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastro intestinal disorders | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| dheas levels | 6 months |
| ovarian volume | 6 months |
| total cholesterol | 6 months |
| tryglycerides levels | 6 months |
| free androgen index | 6 months |
| insulin levels | 6 months |
| hirsutism score | 6 months |
| androstenedione levels | 6 months |
| testosterone levels | 6 months |
| number of cycles in 6 months of therapy | 6 months |
Countries
Italy
Outcome results
None listed