Safety and Efficacy of the Effect of Isosorbide Mononitrate in Reducing Pain During Levonorgestrel-releasing Intrauterine Device Insertion

Overview

the aim of the study is to evaluate the safety and efficacy of isosorbide mononitrate vaginal administration in reducing pain during LNG-IUD insertion in adolescents and young women

Full Title of Study: “Safety and Efficacy of the Effect of Isosorbide Mononitrate in Reducing Pain During Levonorgestrel-releasing Intrauterine Device Insertion in Adolescents and Young Women”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 25, 2020

Interventions

  • Drug: Isosorbide Mononitrate 40 MG
    • one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to LNG- IUD insertion
  • Drug: Placebo
    • one tablet of placebo vaginally 3 hours prior to LNG-IUD insertion

Arms, Groups and Cohorts

  • Experimental: Isosorbide Mononitrate
    • one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to LNG-IUD insertion
  • Placebo Comparator: placebo
    • one tablet of placebo vaginally 3 hours prior to LNG- IUD insertion

Clinical Trial Outcome Measures

Primary Measures

  • 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 10 on a 10 cm horizontal straight line, where ‘zero’ corresponds to no pain at all, and ’10’ to the worst possible pain imaginable.

Secondary Measures

  • duration of IUD insertion
    • Time Frame: 5 minutes
    • duration of IUD insertion from speculum in to speculum out in minutes

Participating in This Clinical Trial

Inclusion Criteria

  • adolescents and young women requesting LNG-IUD insertion Exclusion Criteria:

  • heavy vaginal bleeding,pregnancy, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly

Gender Eligibility: Female

Minimum Age: 14 Years

Maximum Age: 25 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmed Samy aly ashour, assistant professor obstetrics and gynecology – Cairo University
  • Overall Contact(s)
    • AHMED SAMY, +201100681167, ahmedsamy8233@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.