NCT03187392

Brief Summary

The aim of our study is to compare the analgesic effect of topical application of lidocaine-prilocaine cream and lidocaine infiltration during insertion of birth control implants

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

June 12, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2018

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

June 13, 2017

Last Update Submit

February 25, 2018

Conditions

ContraceptionLidocaine

Outcome Measures

Primary Outcomes (1)

  • Mean pain score during insertion of implant

    10 minutes

Study Arms (2)

lidocaine injection

ACTIVE COMPARATOR
Drug: Lidocaine Injectable Product

lidocaine-prilocaine cream

EXPERIMENTAL
Drug: Lidocaine Topical Cream [LMX]

Interventions

Lidocaine Injectable ProductDRUG

3 cm of Lidocaine- will be injected subcutaneous for 5 minutes before insertion of subcutaneous birth control implant

lidocaine injection
Lidocaine Topical Cream [LMX]DRUG

3 mg of Lidocaine- will be applied to skin for 5 minutes before insertion of subcutaneous birth control implant

lidocaine-prilocaine cream

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • female want use subcutaneous birth control

You may not qualify if:

  • previous scar at side of insertion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicine

Asyut, Egypt

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident physician

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 15, 2017

Study Start

June 12, 2017

Primary Completion

September 16, 2018

Study Completion

September 18, 2018

Last Updated

February 27, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)