Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome|
- Plasma concentration of metformin [ Time Frame: First day after administration until 3 months after begining of treatment ] [ Designated as safety issue: No ]Blood samples are collected from each patient and the plasma concentration is analysed.
- Number of adverse events [ Time Frame: observation during 3 months of treatment ] [ Designated as safety issue: No ]All adverse events are registered during the treatment
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
study parallel with one arm only.
Metformin 500 mg tablet (1000 or 1500 mg/day)
Other Name: Glifage 500 mg
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366391
|Contact: Naura Angonese, Dr||+55 45 2103 firstname.lastname@example.org|
|Contact: Josélia Manfio, Dr||+55 45 email@example.com|
|Toledo, Parana, Brazil, 85903-590|
|Contact: Joselia Manfio, Dr +55 45 2103 1907 firstname.lastname@example.org|
|Contact: Naura Angonese, Dr +55 45 2103 1900 email@example.com|
|Principal Investigator: Naura Angonese, Dr|
|Principal Investigator:||Naura Angonese, Dr||Biocinese|