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Completed

NCT Number: NCT04312048

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

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

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Key information

Conditions

IUD Insertion Pain

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ahmed Samy

Giza, 11231, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isosorbide Mononitrate

Drug

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

Placebo

Drug

one tablet of placebo vaginally 3 hours prior to copper IUD insertion

Primary outcomes

  1. 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 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 outcomes

  1. duration of IUD insertion

    Time frame: 5 minutes

    duration of IUD insertion from speculum in to speculum out

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 18, 2020
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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