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Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs

NCT02479256 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2016-05-17

No results posted yet for this study

Summary

Comparison between Clomiphene citrate and Tamoxifen for induction of ovulation in women with PCOS.

Conditions

  • PCOS

Interventions

DRUG

Clomiphene citrate

Women will receive one tablet of clomiphene citrate oral tablets 50 mg (Clomid®, aventis/Egypt) twice daily 12 hours apart (total dose 100 mg daily) from the 3rd day of the menses for 5 days, for only one menstrual cycle.

DRUG

Tamoxifen Placebo

Women will receive one tablet of placebo of tamoxifen oral tablets twice daily 12 hours apart from the 3rd day of the menses for 5 days, for only one menstrual cycle.

DRUG

Tamoxifen

Women will receive one tablet of tamoxifen oral tablets 10 mg (Tamoxifen®, amriya/Egypt) twice daily 12 hours apart (total dose 20 mg daily) from 3rd day of the menses for 5 days, for only one menstrual cycle.

DRUG

Clomiphene citrate placebo

Women will receive one tablet of placebo of clomiphene citrate twice daily 12 hours apart from 3rd day of the menses for 5 days, for only one menstrual cycle.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Gasser M. El-Bishry, FRCOG · Professor of Obstetrics and Gynaecology, Ain Shams University

  • Abdel-Latif G. El-Kholy, MD · Assistant professor of Obstetrics and Gynaecology, Ain Shams University

  • Mohamed S. Sweed, MD · Lecturer of Obstetrics and Gynaecology, Ain Shams University

  • Diana N. Kolta, MB BCh · Resident of Obstetrics and Gynaecology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-05-31
Completion
2016-05-31

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 NCT02479256 on ClinicalTrials.gov