NCT04339049

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2021

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

December 10, 2021

Status Verified

November 1, 2021

Enrollment Period

1.2 years

First QC Date

April 7, 2020

Last Update Submit

November 28, 2021

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

  • pain during IUD insertion

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

    5 minutes

Secondary Outcomes (1)

  • duration of IUD insertion

    5 minutes

Study Arms (3)

lidocaine spray

EXPERIMENTAL

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

Drug: lidocaine spray

vaginal misoprostol

ACTIVE COMPARATOR

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

Drug: vaginal misoprostol

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

lidocaine sprayDRUG

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

lidocaine spray
vaginal misoprostolDRUG

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

vaginal misoprostol
placeboDRUG

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

placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • adolescent and young nulliparous women requesting IUD insertion

You may not qualify if:

  • multiparous women, contraindications to IUD insertion or to study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Ashour

Giza, 12944, Egypt

Location

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 8, 2020

Study Start

May 1, 2020

Primary Completion

July 17, 2021

Study Completion

July 30, 2021

Last Updated

December 10, 2021

Record last verified: 2021-11

Locations

EG(1)