NCT02658773

Brief Summary

The purpose of the investigators' study was to evaluate whether cervical lidocaine-Prilocaine cream will improve pain scores compared to placebo. The investigators hypothesized that lidocaine-Prilocaine cream will reduce the insertion pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

January 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

4 months

First QC Date

January 15, 2016

Last Update Submit

August 7, 2016

Conditions

IUD Pain

Outcome Measures

Primary Outcomes (1)

  • Mean pain score during IUD insertion

    5 minutes

Study Arms (2)

lidocaine-Prilocaine cream

ACTIVE COMPARATOR

lidocaine-Prilocaine anesthetic cream placed into their cervix prior to having the IUD inserted

Drug: lidocaine-Prilocaine cream

placebo cream

PLACEBO COMPARATOR

an inert placebo cream placed into their cervix

Drug: placebo cream

Interventions

lidocaine-Prilocaine creamDRUG
lidocaine-Prilocaine cream
placebo creamDRUG
placebo cream

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women not taken analgesics or anxiolytics in the 24 hours prior insertion
  • Women not taken misoprostol prior to IUD insertion
  • No contraindication to or history of allergic reaction to lidocaine
  • Women who will accept to participate in the study

You may not qualify if:

  • Lidocaine allergy
  • Any contraindication to IUD placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 20, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

August 9, 2016

Record last verified: 2016-08

Locations

EG(1)