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Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

NCT00953641 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2012-08-14

No results posted yet for this study

Summary

The purpose of this study is to determine whether using Misoprostol vaginally before an office endometrial biopsy is performed, will make it easier, more successful and less painful to do the procedure.

The investigators' hypothesis is that vaginal Misoprostol 12 hours prior to endometrial biopsy will increase the ease of performing office endometrial biopsy by reducing the need to use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle.

Conditions

  • Menorrhagia
  • Endometrial Biopsy
  • Cervical Ripening

Interventions

DRUG

Misoprostol

Misoprostol 400ug, suspended in a base (Witepsol 15) as a vaginal suppository Single dose 12h or more prior to the procedure

DRUG

Placebo

Witepsol 15 base, vaginal suppository, Single dose, 12h or more prior to the endometrial biopsy

Sponsors & Collaborators

  • University of Saskatchewan

    lead OTHER

Principal Investigators

  • Roger Pierson, PhD · University of Saskatchewan, Dept. of Obstetrics and Gynecology, College of Medicine

  • Anita Harding, MBChB · University of Saskatchewan, Dept. of Obstetrics and Gynecology, College of Medicine

  • Thirza Smith, MD, FRCS · University of Saskatchewan, Dept. of Obstetrics and Gynecology

  • Marilyn Davidson, FRCSC · University of Saskatchewan, Dept. of Obstetrics and Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Canada

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 NCT00953641 on ClinicalTrials.gov