Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin

study parallel with one arm only.

Group Type OTHER

Metformin

Intervention Type DRUG

Metformin 500 mg tablet (1000 or 1500 mg/day)

Interventions

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Metformin

Metformin 500 mg tablet (1000 or 1500 mg/day)

Intervention Type DRUG

Other Intervention Names

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Glifage 500 mg

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No