Lidocaine In-situ Gel Before Intrauterine Device Insertion | NCT02943135

Studies
Lidocaine In-situ Gel Before Intrauterine Device Insertion

NCT02943135

Sponsor

Assiut University

Status

Completed

Last Update Posted

May 20, 2020Actual

Enrollment

120Actual

Phase

Phase 3

Conditions

Pain Relief

Interventions

lidocaine in-situ gel
placebo in-situ gel

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Mar 30, 2020Actual

First Submitted Date

Oct 21, 2016

First Submission Date that Met QC Criteria

Oct 21, 2016

First Posted Date

Oct 24, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2020

Last Update Posted Date

May 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
lidocaine in-situ gel	Drug	lidocaine in-situ gel	lidocaine in-situ

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean pain score during intrauterine device insertion		30 min

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Lidocaine allergy
Any contraindication to device placement

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Abbas		Assiut	Cairo Governorate	002	Egypt
Assiut University

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided