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Metformin in Infertile PCOS Patients

NCT00501904 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-12-03

No results posted yet for this study

Summary

Metformin, an oral biguanide administrated for treating type-2 diabetes mellitus, is a safe and effective drug recently experimented also in patients with polycystic ovary syndrome (PCOS). The administration of metformin induces ovulatory cycles in CC-resistant or -nonresistant patients with PCOS, and improves the ovulation rate as an additional treatment in women who received CC.

To date, it is unknown the best protocol for metformin administration. In particular, it is not known how long patients who ovulate under metformin should continue treatment before switching to second-line ovulation induction therapy. In this regard, in a recent study by the Kaplan-Meier survival analysis we demonstrated that the first pregnancy occurred late after metformin with an estimated median of seven months.

Based on these considerations, the aim of the present study will be to evaluate the clinical efficacy of metformin according to its duration of administration in infertile PCOS patients ovulating under treatment.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

Metformin

Sponsors & Collaborators

  • University Magna Graecia

    lead OTHER

Principal Investigators

  • Stefano Palomba, MD · Department of Obstetrics & Gynecology, University "Magna Graecia" of Catanzaro

  • Francesco Orio, MD · Department of Endocrinology, University "Federico II" of Naples

  • Achille Tolino, MD · Department of Obstetrics & Gynecology, University "Federico II" of Naples

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2016-06-30
Completion
2016-12-31

Countries

  • Italy

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 NCT00501904 on ClinicalTrials.gov