NCT02943135

Brief Summary

Intrauterine device can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the insertion tube, and removing the tube; and placement of the device in the uterus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

2 active sites

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

October 21, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

2.2 years

First QC Date

October 21, 2016

Last Update Submit

May 19, 2020

Conditions

Pain Relief

Outcome Measures

Primary Outcomes (1)

  • Mean pain score during intrauterine device insertion

    30 min

Study Arms (2)

lidocaine in-situ

ACTIVE COMPARATOR

Self-administered gel 10 min before intrauterine device insertion

Drug: lidocaine in-situ gel

placebo

PLACEBO COMPARATOR

Self-administered gel 10 min before intrauterine device insertion

Drug: placebo in-situ gel

Interventions

lidocaine in-situ gelDRUG

lidocaine in-situ gel

lidocaine in-situ
placebo in-situ gelDRUG

placebo in-situ gel

placebo

Eligibility Criteria

Age20 Years - 50 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 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 device placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

Assiut University

Asyut, Egypt

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 21, 2016

First Posted

October 24, 2016

Study Start

October 1, 2017

Primary Completion

December 31, 2019

Study Completion

March 30, 2020

Last Updated

May 20, 2020

Record last verified: 2020-05

Locations

EG(2)