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

Cairo University88 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Contraception

Interventions

Isosorbide Mononitrate 40 MGDRUG

one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to LNG- IUD insertion

PlaceboDRUG

one tablet of placebo vaginally 3 hours prior to LNG-IUD insertion

Eligibility

Sex: FEMALEMin age: 14 YearsMax age: 25 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

pain during IUD insertion

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.

Time frame: 5 minutes

Secondary Outcomes

duration of IUD insertion

duration of IUD insertion from speculum in to speculum out in minutes

Time frame: 5 minutes

Central Contacts

AHMED SAMY

CONTACT

+201100681167 ahmedsamy8233@gmail.com

Data from ClinicalTrials.gov

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