Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome

Biocinese

Status and phase

Unknown

Phase 4

Conditions

Polycystic Ovary Syndrome

Treatments

Drug: Metformin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01366391

0038.0 208.00-09

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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