NCT07155785

Brief Summary

Investigators aimed to investigate the effectiveness of the use of local lidocaine spray application to make routine intrauterine intrauterine device application more painless.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

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

July 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

March 13, 2024

Last Update Submit

August 27, 2025

Conditions

Intrauterine Device MigrationPain

Keywords

intrauterine devicepain

Outcome Measures

Primary Outcomes (1)

  • Pain component

    Reduction of the pain felt during application of the intrauterine device

    1 hour

Study Arms (2)

Active group

ACTIVE COMPARATOR

This group received lidocaine spray during intrauterine device application.

Drug: Lidocain spray

Placebo group

PLACEBO COMPARATOR

This group received saline spray during intrauterine device application.

Drug: Lidocain spray

Interventions

Lidocain sprayDRUG

Lidocaine spray as a local anaesthetic agent was applied to the cervix before intrauterine device application.

Active groupPlacebo group

Eligibility Criteria

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

You may qualify if:

  • years old patient who comes to have an intrauterine device inserted voluntarily
  • The patient who gave consent to participate in the study

You may not qualify if:

  • Patients who cannot have an intrauterine device because of fibroids or cervical stenosis
  • Patient who did not want to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intrauterine Device MigrationPain

Condition Hierarchy (Ancestors)

Foreign-Body MigrationForeign BodiesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
off labeled and hidden bottle usage during spray apply
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: double blind randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 13, 2024

First Posted

September 4, 2025

Study Start

July 1, 2022

Primary Completion

February 20, 2023

Study Completion

May 25, 2023

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Only the results of the patients can be shared

Locations

TU(1)