NCT04339361

Brief 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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
111

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2020

Shorter than P25 for phase_4

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

April 25, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

April 7, 2020

Last Update Submit

April 7, 2020

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

  • pain during IUD insertion

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

    2 minutes

Secondary Outcomes (1)

  • insertion duration

    5 minutes

Study Arms (3)

lidocaine spray

EXPERIMENTAL

four puffs (50ml, 10 mg/puff) of lidocaine spray will be applied to the cervical canal and cervix before tenaculum placement plus vaginal placebo will be given 3 hours before IUD insertion

Drug: lidocaine spray

vaginal dinoprostone

ACTIVE COMPARATOR

vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray will be applied to the cervical canal and cervix before tenaculum placement

Drug: vaginal dinoprostone

placebo

PLACEBO COMPARATOR

vaginal placebo will be given 3 hours before IUD insertion plus four puffs of saline spray will be applied to the cervical canal and cervix before tenaculum placement

Drug: placebo

Interventions

lidocaine sprayDRUG

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

lidocaine spray
vaginal dinoprostoneDRUG

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

vaginal dinoprostone
placeboDRUG

vaginal placebo will be 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:

  • nulliparous women requesting levonorgestrel IUD insertion

You may not qualify if:

  • multiparous women, allergy or contraindication to study drugs or contraindications to LNG-IUD insertion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

AHMED SAMY

CONTACT

+201100681167ahmedsamy8233@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
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 25, 2020

Primary Completion

August 10, 2020

Study Completion

August 15, 2020

Last Updated

April 9, 2020

Record last verified: 2020-04