Polycystic Ovary Syndrome
Conditions
Keywords
polycystic ovary syndrome, metformin, pharmacokinetic
Brief summary
Metformin is one of the most commonly prescribed drugs worldwide for the treatment of Type 2 Diabetes. It has been currently used for the treatment of: polycystic ovary syndrome, gestational diabetes, metabolic syndrome and obesity. In patients with polycystic ovary syndrome (PCOS) the adverse side effects are a frequent cause for treatment discontinuation. In every day medical practice lower doses of Metformin are administered searching for the continuation of the treatment. However, there is no clinical study to support this assertion. The objective of this study is to monitor and correlate the therapeutic effect of Metformin on patients with PCOS taking daily doses of 1500mg and 1000mg.
Detailed description
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.
Interventions
DRUGMetformin
Metformin 500 mg tablet (1000 or 1500 mg/day)
Sponsors
Biocinese
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 18 and 40 years old, with no use of contraceptive drugs or insulin sensitizing agents for more than 3 months. * PCOS diagnosis. * Insulin resistance Index by the Homeostatic model Assessment Formula higher than 2.5.
Exclusion criteria
* Another diseases with androgen excess; * Patients with history of serious adverse reaction or hypersensibility to any medicine; * History or presence of renal, hepatic or gastrointestinal disorders. * Continuous use of any pharmaco, inclusively metformin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of metformin | First day after administration until 3 months after begining of treatment | Blood samples are collected from each patient and the plasma concentration is analysed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | observation during 3 months of treatment | All adverse events are registered during the treatment |
Countries
Brazil
Contacts
Primary ContactNaura Angonese, Dr
Backup ContactJosélia Manfio, Dr
Outcome results
None listed