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Topical Lidocaine on the Cervix and Intra-Cervical Prior to Insertion of Intrauterine Devices

NCT01192490 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2011-06-16

No results posted yet for this study

Summary

The hypothesis of this study is that topical cervical and intra-cervical lidocaine will decrease pain associated with the insertion of a Mirena® (levonorgestrel intrauterine device).

1\. Primary Aim- Determine if topical lidocaine intra-cervically and on the cervix decreases the pain associated with insertion of a Mirena® (levonorgestrel intrauterine device).

Conditions

  • Contraception

Interventions

DRUG

Lidocaine

5cc of 2% Lidocaine gel will be placed on the cervix and intra-cervically prior to placement of a Mirena

DRUG

Lubricant

KY Gel will be placed on the cervix and intra-cervically prior to placement of the Mirena

Sponsors & Collaborators

  • University of Tennessee

    lead OTHER

Principal Investigators

  • Kirk Brody, MD · University of Tennessee Chattanooga Department of Obstetrics and Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-09-30
Completion
2012-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01192490 on ClinicalTrials.gov