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Comparative Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in IUD Insertion

NCT04339361 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2020-04-09

No results posted yet for this study

Summary

the aim of this study is to compare the safety and Efficacy of Lidocaine Spray Versus Vaginal dinoprostone in relieving pain during levonorgestrel IUD Insertion in nulliparous women

Conditions

  • Contraception

Interventions

DRUG

lidocaine spray

four puffs (50 ml, 10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion

DRUG

vaginal dinoprostone

vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

DRUG

placebo

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-25
Primary Completion
2020-08-10
Completion
2020-08-15

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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 NCT04339361 on ClinicalTrials.gov