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Letrozole or Combined Metformin Clomiphene Citrate (CC) for Women With CC Resistant Polycystic Ovary Syndrome

NCT00911313 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2009-06-01

No results posted yet for this study

Summary

The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

Letrozole tablets (Femara; Novartis Pharma, Switzerland)

2.5 mg letrozole daily from day 3 of the menses for 5 days

DRUG

metformin HCl (Cidophage®; CID,Cairo, Egypt)

metformin HCl 1500 daily for 6-8 weeks

DRUG

CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt)

150 mg CC for 5 days starting from day 3 of menstruation

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Hatem Abu Hashim, MD. MRCOG · Mansoura University Hospital

  • Tarek Shokair, MD · Mansoura University Hospital

  • Ahmed Badawy, MD.PhD. · Mansoura University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
36 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Egypt

Study Locations

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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 NCT00911313 on ClinicalTrials.gov