Skip to main content
OpenTrials
Completed

NCT Number: NCT02708251

Glyceryl Trinitrate Versus Lidocaine Cream for IUD Insertion

The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive method that may be underutilized due to fear of pain during insertion. Although providers frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no evidence for any pain reduction. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

IUD Insertion

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women not taken analgesics or anxiolytics in the 24 hours prior insertion
  • Women not taken misoprostol prior to IUD insertion
  • No contraindication to or history of allergic reaction to lidocaine or NO donors.
  • Women who will accept to participate in the study

Exclusion criteria

  • Lidocaine allergy
  • History of migraine or chronic headache
  • Any contraindication to IUD placement

Treatment and study plan

glyceryl trinitrate cream

Drug

Lidocaine Cream

Drug

placebo cream

Drug

Primary outcomes

  1. Mean pain score during IUD insertion

    Time frame: 3 minutes

Secondary outcomes

  1. Patient satisfaction score after the procedure

    Time frame: 3 minutes

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Topical Glyceryl Trinitrate Versus Lidocaine Cream as Analgesia for IUD Insertion: A Randomized Controlled Trial

Acronym: GTN-IUD

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 15, 2016
Registry last updated
Jul 13, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.