Clinical Trial: Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Biocinese

Current Primary Outcome: Plasma concentration of metformin [ Time Frame: First day after administration until 3 months after begining of treatment ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of adverse events [ Time Frame: observation during 3 months of treatment ]

All adverse events are registered during the treatment


Original Secondary Outcome: Same as current

Information By: Biocinese

Dates:
Date Received: June 2, 2011
Date Started: January 2011
Date Completion: October 2011
Last Updated: June 3, 2011
Last Verified: June 2011