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Vaginal Dinoprostone Versus Vaginal Misoprostol Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients

NCT04044079 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-09-01

No results posted yet for this study

Summary

To compare the effectiveness of vaginal dinoprostone and vaginal misoprostol with placebo in minimizing the pain experienced by postmenopausal patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.

Conditions

  • Office Hysteroscopy

Interventions

DRUG

Dinoprostone

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.

DRUG

Misoprostol

Misoprostol (200µg) will be administered vaginally 12 hours before office hysteroscopy.

DRUG

Placebo

one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • AHMED SAMY · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-20
Primary Completion
2020-01-10
Completion
2020-02-10

Countries

  • Egypt

Study Locations

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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 NCT04044079 on ClinicalTrials.gov