Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome

Phase 4

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Metformin

• Registration Number: NCT01366391
• Lead Sponsor: Biocinese

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Status Verified: 2011-06
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-03
• Last Update Submitted: 2011-06-03
• Study First Posted: 2011-06-06
• Last Update Posted: 2011-06-06
• Primary Completion: 2011-08
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 24

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	study parallel with one arm only.

Primary Outcome Measures

Name	Time	Method
Plasma concentration of metformin	First day after administration until 3 months after begining of treatment	Blood samples are collected from each patient and the plasma concentration is analysed.

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	observation during 3 months of treatment	All adverse events are registered during the treatment

Trial Locations

Locations (1)

Biocinese; 🇧🇷 Toledo, Parana, Brazil