MedTrace Logo

Vaginal Isonicotinic Acid Hydrazide Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System

NCT04500028 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2022-05-13

No results posted yet for this study

Summary

To investigate whether vaginal isonicotinic acid hydrazide (INH) administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in Women With no Previous Vaginal Delivery.

Conditions

  • IUCD Complication

Interventions

DRUG

INH

3 vaginal tablet of isonicotinic acid hydrazide (900mg) inserted by the study nurse 4 hours before IUD insertion.

DRUG

Placebo Comparator

3 tablet of placebo inserted by the study nurse 4 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
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-10-31
Completion
2021-12-01

Countries

  • Egypt

Study Locations

More Related Trials

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 NCT04500028 on ClinicalTrials.gov