NCT02020551

Brief Summary

Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Misoprostol and nonsteroidal drugs have found to be ineffective by clinical trials.Investigators tested whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
223

participants targeted

Target at P75+ for not_applicable pain

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

May 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 25, 2013

Completed
Last Updated

December 25, 2013

Status Verified

December 1, 2013

Enrollment Period

3 months

First QC Date

December 11, 2013

Last Update Submit

December 24, 2013

Conditions

Pain

Keywords

Scores During IUD insertion.

Outcome Measures

Primary Outcomes (1)

  • Pain

    10 cm VAS scale

    3 months

Study Arms (2)

saline spray application

PLACEBO COMPARATOR

Placebo group

Drug: Placebo

lidocaine spray application

EXPERIMENTAL

2 puff lidocaine spray applicated before IUD insertion

Drug: Lidocaine Spray

Interventions

Lidocaine SprayDRUG
lidocaine spray application
PlaceboDRUG
saline spray application

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age \>18 Not pregnant Smear negative

You may not qualify if:

  • Chronic pelvic pain Pregnancy Uterine anomaly Fibroid Acute cervicitis Pelvic inflammatory disease Cervical stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri Education and Research Hospital of Medicine

Kayseri, 380210, Turkey (Türkiye)

Location

Related Publications (1)

  • Aksoy H, Aksoy U, Ozyurt S, Acmaz G, Babayigit M. Lidocaine 10% spray to the cervix reduces pain during intrauterine device insertion: a double-blind randomised controlled trial. J Fam Plann Reprod Health Care. 2016 Apr;42(2):83-7. doi: 10.1136/jfprhc-2014-100917. Epub 2015 Mar 10.

    PMID: 25759418DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic 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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 11, 2013

First Posted

December 25, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2013

Last Updated

December 25, 2013

Record last verified: 2013-12

Locations

TU(1)