Know Cancer

or
forgot password

Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome


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

Thank you

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
medicine;

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

- Continuous use of any pharmaco, inclusively metformin

Type of Study:

Interventional

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:

No

Principal Investigator

Naura Angonese, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Biocinese

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

0038.0 208.00-09

NCT ID:

NCT01366391

Start Date:

January 2011

Completion Date:

October 2011

Related Keywords:

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

Name

Location