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Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:
Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01366391
Study type Interventional
Source Biocinese
Contact Naura Angonese, Dr
Phone +55 45 2103 1900
Email naura.tonin@hotmail.com
Status Recruiting
Phase Phase 4
Start date January 2011
Completion date October 2011
View Details
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