NCT03166111

Lidocaine In-situ Gel Prior to Intrauterine Device Insertion in Women With no Previous Vaginal Delivery

Effect of Self-administered Lidocaine In-situ Gel Prior to Intrauterine Device Insertion in Women With no Previous Vaginal Delivery: A Randomized Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one. Pre-insertion oral ibuprofen, diclofenac, nitroprusside, local anesthetics as lidocaine and prostaglandins has been reported with variable degrees of success .

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	lidocaine gel	syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion
DRUG	placebo gel	syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion

Timeline

• Start date: 2017-09-01
• Primary completion: 2020-03-31
• Completion: 2020-05-31
• First posted: 2017-05-24
• Last updated: 2020-10-06

Locations

1 site across 1 country: Egypt