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

Phase 3

Completed

• Conditions: IUD Insertion Pain
• Interventions: Drug: placebo; Drug: Isosorbide mononitrate

• Registration Number: NCT04312048
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-14
• Study First Submitted QC: 2020-03-14
• Study First Posted: 2020-03-18
• Study Start: 2020-04-15
• Primary Completion: 2020-10-25
• Study Completion: 2020-11-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-16
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	one tablet of placebo vaginally 3 hours prior to copper IUD insertion
Isosorbide Mononitrate	Isosorbide mononitrate	one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to copper 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 100 on a 100 mm horizontal straight line, where 'zero' corresponds to no pain at all, and '100' 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

Trial Locations

Locations (1)

Ahmed Samy; 🇪🇬 Giza, Egypt