Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Levonorgestrel IUD Insertion

NCT04339348 | Completed Phase 3

• 1 other identifier: misoprostol vs LP cream
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

the aim of the present study is to compare the safety and Efficacy of vaginal misoprostol versus Lidocaine-prilocaine cream in reducing pain during levonorgestrel IUD Insertion in women delivered only by cesarean deliveries

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• pain during LNG-IUD insertion

  pain during LNG-IUD insertion evaluated by 10 cm visual analog scale where 0 denotes no pain and 10 denotes the worst imaginable pain

  5 minutes

Secondary Outcomes (1)

• duration of insertion

  5 minutes

Study Arms (3)

vaginal misoprostol

EXPERIMENTAL

vaginal misoprostol 200 mcg will be given 3 hours before LNG-IUD insertion plus vaginal inert placebo cream at the time of IUD insertion

Drug: vaginal misoprostol

lidocaine prilocaine cream

ACTIVE COMPARATOR

Lidocaine-prilocaine anesthetic cream will be placed on the cervix at the time of IUD insertion plus vaginal placebo will be given 3 hours before LNG-IUD insertion

Drug: Lidocaine-Prilocaine Topical cream

placebo

PLACEBO COMPARATOR

inert vaginal placebo cream will be placed on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours before LNG-IUD insertion

Drug: placebo

Interventions

vaginal misoprostol DRUG

vaginal misoprostol 200 mcg will be given 3 hours before LNG-IUD insertion plus inert placebo cream vaginally at the time of LNG-IUD insertion

vaginal misoprostol

Lidocaine-Prilocaine Topical cream DRUG

Lidocaine-Prilocaine cream will be applied on the cervix at the time of LNG-IUD insertion plus vaginal placebo tablet 3 hours before LNG-IUD insertion

lidocaine prilocaine cream

placebo DRUG

inert placebo cream will be applied on the cervix at the time of LNG-IUD insertion plus vaginal placebo tablet 3 hours before LNG-IUD insertion

placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• women who delivered only by previous cesarean delivery and requesting LNG-IUD insertion

You may not qualify if:

• women who delivered vaginally, active vaginal or cervical infections and contraindications to IUD insertion or study drugs

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmedsamy

Giza, 12511, Egypt

Location

Study Officials

• ahmed taher, MD

  Cairo University

  STUDY DIRECTOR

• sherif dahab, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

• tarek el husseiny

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor obstetrics and gynecology

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 9, 2020
• Study Start: April 30, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

EG (1)