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

IUD Insertion Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04312048
• Other study ID #: 00249
• Status: Completed
• Phase: Phase 3
• Start date: April 15, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: January 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 30, 2020
• Est. primary completion date: October 25, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• IUD Insertion Pain

Intervention

Drug:
• Isosorbide mononitrate
one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to copper IUD insertion
• placebo
one tablet of placebo vaginally 3 hours prior to copper IUD insertion

Locations

Country	Name	City	State
Egypt	Ahmed Samy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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	duration of IUD insertion	duration of IUD insertion from speculum in to speculum out	5 minutes