Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients

NCT03683914 | Completed Phase 4

• 1 other identifier: vaginal dinoprostone
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effectiveness of vaginal dinoprostone with placebo in minimising 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 (2)

dinoprostone arm

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 3Mg Vaginal Tablet

placebo

PLACEBO COMPARATOR

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

Drug: placebo vaginal tablet

Interventions

Dinoprostone 3Mg Vaginal Tablet DRUG

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

dinoprostone arm

placebo vaginal tablet DRUG

1 vaginal tablet of placebo inserted by the patient 12 hours before the scheduled office diagnostic 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 therapy (asthma, liver, kidney, or heart disease).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine Cairo University

Cairo, 11231, Egypt

Location

MeSH Terms

Interventions

Dinoprostone; Vaginal Creams, Foams, and Jellies

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Officials

• AHMED SAMY, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in obstetrics and gynecology

Study Record Dates

• First Submitted: September 22, 2018
• First Posted: September 25, 2018
• Study Start: September 30, 2018
• Primary Completion: January 30, 2019
• Study Completion: February 28, 2019
• Last Updated: March 26, 2019

Record last verified: 2019-03

Locations

EG (1)