Vaginal Isonicotinic Acid Hydrazide Administration Prior to Intrauterine Device Insertion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-08-30

Brief Summary

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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.

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Detailed Description

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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

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IUCD Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blind randomized controlled study

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

double blind randomized controlled study

Study Groups

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INH

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

Group Type EXPERIMENTAL

INH

Intervention Type DRUG

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

Placebo Comparator

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

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

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

Interventions

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INH

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

Intervention Type DRUG

Placebo Comparator

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No