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An RCT of Metformin Vs Orlistat in Obese Anovulatory Women

NCT00292799 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-09-27

No results posted yet for this study

Summary

This study aims to investigate the role of the weight reduction agent, Orlistat compared to the Metformin for the management of women who are obese and do not ovulate or have difficulty conceiving. Patients will receive either one of these medications and will be monitored at regular intervals with hormone blood tests and ultrasound scans in order to study the effect of the medications on the reproductive functions. Patients will receive the medications for three months and the study will end if the patient becomes pregnant. The study also aims to investigate the dose of metformin that should be used as there is no consensus to date regarding the optimum dosage for this drug

Conditions

Interventions

DRUG

Orlistat Vs Metformin

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Professor William L Ledger, D.Phil,FRCOG · Sheffield University

  • Dr Mostafa Metwally · Sheffield University

  • Professor TC Li · Sheffield Teaching Hospitals NHS Foundation Trust

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
2006-02-28
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

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 NCT00292799 on ClinicalTrials.gov