NCT04500015

Vaginal Isonicotinic Acid Hydrazide Administration Prior to Intrauterine Device Insertion

Benefits of Self-administered Vaginal Isonicotinic Acid Hydrazide (INH) Administration 12 Hours Prior to Intrauterine Device Insertion in Adolescent and Young Women: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Aswan University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

To investigate whether vaginal isonicotinic acid hydrazide administered before the levonorgestrel-releasing intrauterine system insertion reduces IUD insertion pain and difficulty in insertion in adolescents and young women.

Detailed description

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.

Conditions

• IUCD Complication

Interventions

Type	Name	Description
DRUG	INH	3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.
DRUG	Placebo Comparator	3 tablet of placebo self-inserted by the patient 12 hours before IUD insertion.

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-06-30
• Completion: 2021-08-30
• First posted: 2020-08-05
• Last updated: 2021-09-29

Locations

1 site across 1 country: Egypt