Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome
Patients with PCOS diagnosis and that are able to attempt the inclusion criteria are divided
in two groups: administration of metformin 500 mg tablet three times/day as well 1500 mg/day
(group A)and administration of metformin 500 mg tablet twice/day or 1000 mg/day (group B).
Blood samples were collected to the pharmacokinetic evaluation from first day of
administration until 3 months after beginning of treatment. The patients are monitored
during 3 months and all side effects are register. The efficacy of both treatment are
analyzed by biochemical and physical evaluation.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Plasma concentration of metformin
Blood samples are collected from each patient and the plasma concentration is analysed.
First day after administration until 3 months after begining of treatment
Naura Angonese, Dr
Brazil: National Committee of Ethics in Research