Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in IUD Insertion

NCT04339049 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2021-12-10

No results posted yet for this study

Summary

the aim of the present study is to compare the safety and efficacy of lidocaine spray versus misoprostol in reducing pain during IUD insertion in adolescents and nulliparous women

Conditions

  • Contraception

Interventions

DRUG

lidocaine spray

four puffs (10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion

DRUG

vaginal misoprostol

vaginal misoprostol 200 mcg given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

DRUG

placebo

vaginal placebo given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

Sponsors & Collaborators

  • Algazeerah hospital

    collaborator UNKNOWN
  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2021-07-17
Completion
2021-07-30

Countries

  • Egypt

Study Locations

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Entities

Drugs

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 NCT04339049 on ClinicalTrials.gov