the Effect of Isosorbide Mononitrate in Reducing Pain During Cooper Intrauterine Device Insertion

January 16, 2021 updated by: Ahmed Samy aly ashour, Cairo University

the Effect of Vaginal Isosorbide Mononitrate Administration in Reducing Pain During Cooper Intrauterine Device Insertion in Nulliparous Women : a Randomized Controlled Trial

The aim of the study is to evaluate the efficacy of isosorbide mononitrate vaginal administration in reducing pain during copper IUD insertion in nulliparous women

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 11231
        • Ahmed Samy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • nulliparous women requesting copper IUD device insertion

Exclusion Criteria:

  • parous women, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Isosorbide Mononitrate
one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to copper IUD insertion
Drug: Isosorbide mononitrate
one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to copper IUD insertion
Placebo Comparator: placebo
one tablet of placebo vaginally 3 hours prior to copper IUD insertion
Drug: placebo
one tablet of placebo vaginally 3 hours prior to copper IUD insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain during IUD insertion
Time Frame: 5 minutes
intensity of patient-perceived pain at time of IUD insertion, using a visual analog scale. The VAS scale is graded from 0 to 100 on a 100 mm horizontal straight line, where 'zero' corresponds to no pain at all, and '100' to the worst possible pain imaginable.
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of IUD insertion
Time Frame: 5 minutes
duration of IUD insertion from speculum in to speculum out
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mahmoud alalfy, MD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2020

Primary Completion (Actual)

October 25, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

March 14, 2020

First Submitted That Met QC Criteria

March 14, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 16, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00249

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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