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Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome

Phase 4
18 Years
40 Years
Open (Enrolling)
Polycystic Ovary Syndrome

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Trial Information

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.

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

- History or presence of renal, hepatic or gastrointestinal disorders.

- Continuous use of any pharmaco, inclusively metformin

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Plasma concentration of metformin

Outcome Description:

Blood samples are collected from each patient and the plasma concentration is analysed.

Outcome Time Frame:

First day after administration until 3 months after begining of treatment

Safety Issue:


Principal Investigator

Naura Angonese, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:



Brazil: National Committee of Ethics in Research

Study ID:

0038.0 208.00-09



Start Date:

January 2011

Completion Date:

October 2011

Related Keywords:

  • Polycystic Ovary Syndrome
  • polycystic ovary syndrome
  • metformin
  • pharmacokinetic
  • Polycystic Ovary Syndrome