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

NCT04044079 | Completed Phase 4

• 1 other identifier: dinoprostone misoprostol
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Intensity of pain

  Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10

  an expected average of 10 minutes

Secondary Outcomes (2)

• Intensity of pain

  30 minutes after the procedure

• Operative time

  an expected average 10 minutes

Study Arms (3)

dinoprostone

EXPERIMENTAL

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

Drug: Dinoprostone

misoprostol

ACTIVE COMPARATOR

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

Drug: Misoprostol

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Dinoprostone DRUG

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

dinoprostone

Misoprostol DRUG

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

misoprostol

Placebo DRUG

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

placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)

You may not qualify if:

• Nulliparous patients
• patients with cervical pathology
• retroverted uterus (detected by transvaginal ultrasound)
• previous cervical surgery
• patients with severe vaginal bleeding
• allergy or contraindications to dinoprostone or misoprostol therapy (asthma, liver, kidney, or heart disease).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Samy

Giza, 11231, Egypt

Location

MeSH Terms

Interventions

Dinoprostone; Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Prostaglandins E, Synthetic; Prostaglandins, Synthetic

Study Officials

• AHMED SAMY

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 2, 2019
• Study Start: August 20, 2019
• Primary Completion: January 10, 2020
• Study Completion: February 10, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-08

Locations

EG (1)