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Vaginal Isonicotinic Acid Hydrazide Administration Prior to Intrauterine Device Insertion

NCT04500015 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-09-29

No results posted yet for this study

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.

Conditions

  • IUCD Complication

Interventions

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.

Sponsors & Collaborators

  • Aswan University Hospital

    lead OTHER

Principal Investigators

  • nahla w Shady, md · Aswan universirty

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-06-30
Completion
2021-08-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04500015 on ClinicalTrials.gov