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Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome

NCT01366391 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-06-06

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

Metformin

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

Sponsors & Collaborators

  • Biocinese

    lead INDUSTRY

Principal Investigators

  • Naura Angonese, Dr · Biocinese

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-08-31
Completion
2011-10-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01366391 on ClinicalTrials.gov