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Letrozole Versus Clomifene Citrate for Ovulation Induction

NCT00478504 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2016-10-28

No results posted yet for this study

Summary

The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates with fewer multiple pregnancies and higher live birth rate than the current standard agent, clomifene citrate in anovular infertile women with polycystic ovarian syndrome.

Conditions

Interventions

DRUG

Letrozole

Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5 mg daily if there is no response to 2.5 mg

DRUG

Clomifene citrate

Starting daily dose 50 mg on menstrual cycles days 2 to 6, to be increased to 100 mg daily if there is no response to 50 mg

Sponsors & Collaborators

  • University Hospitals of Derby and Burton NHS Foundation Trust

    collaborator OTHER

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Saad Amer, MD, MRCOG · University of Nottingham and Derby Hospitals NHS foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2014-06-30
Completion
2014-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

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 NCT00478504 on ClinicalTrials.gov