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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04500015

Enrollment

130

Registered

2020-08-05

Start date

2020-09-01

Completion date

2021-08-30

Last updated

2021-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IUCD Complication

Brief 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.

Interventions

DRUGINH

3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.

DRUGPlacebo Comparator

3 tablet of placebo self-inserted by the patient 12 hours before IUD insertion.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double blind randomized controlled study

Intervention model description

double blind randomized controlled study

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 25 Years

Healthy volunteers

Inclusion criteria

* nulliparous adolescent and young women requesting levonorgestrel-releasing intrauterine device

Exclusion criteria

* pregnancy and * contraindication or allergy to or contraindication to IUD insertion, * chronic pelvic pain, * pelvic inflammatory disease, * analgesic intake 24 hours prior to IUD insertion.

Design outcomes

Primary

Measure	Time frame	Description
The difference in pain scores during intrauterine device insertion	10 minutes	The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10

Secondary

Measure	Time frame	Description
duration of IUD insertion	10 minutes	duration of IUD insertion measured in minutes
Provider ease of insertion	10 minutes	Provider ease of insertion was evaluated using a visual analog scale from 0 to 10 cm where 0 denotes very easy insertion and 10 denotes a very difficult insertion.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026