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

Phase 3

• Conditions: Contraception
• Interventions: Drug: Placebo; Drug: Isosorbide Mononitrate 40 MG

• Registration Number: NCT04311658
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-14
• Study First Submitted QC: 2020-03-14
• Last Update Submitted: 2020-03-14
• Study First Posted: 2020-03-17
• Last Update Posted: 2020-03-17
• Study Start: 2020-03-30
• Primary Completion: 2020-06-25
• Study Completion: 2020-07-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	one tablet of placebo vaginally 3 hours prior to LNG- IUD insertion
Isosorbide Mononitrate	Isosorbide Mononitrate 40 MG	one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to LNG-IUD insertion

Primary Outcome Measures

Name	Time	Method
pain during IUD insertion	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 Outcome Measures

Name	Time	Method
duration of IUD insertion	5 minutes	duration of IUD insertion from speculum in to speculum out in minutes