Status:
UNKNOWN
Topical Lidocaine on the Cervix and Intra-Cervical Prior to Insertion of Intrauterine Devices
Lead Sponsor:
University of Tennessee
Conditions:
Contraception
Eligibility:
FEMALE
Phase:
NA
Brief 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-...
Detailed Description
There have been multiple studies performed to determine a medication that will decrease the pain associated with intrauterine device insertion. These studies have tested the use of misoprostol as well...
Eligibility Criteria
Inclusion
- Any subject receiving a Mirena® (levonorgestrel intrauterine device) for standard indications.
- Subjects who received nonsteroidal anti-inflammatory drugs (NSAIDS) will not be excluded.
Exclusion
- Subjects do not desire to be involved in the study
- Subjects who have taken narcotics.
- If the Mirena® (levonorgestrel intrauterine device) is not able to be successfully placed.
- If cervical dilation is required, these subjects will be placed in a separate subset and will be reported on separately.
- Subject has allergy to lidocaine.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01192490
Start Date
August 1 2010
End Date
December 1 2012
Last Update
June 16 2011
Active Locations (1)
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1
University of Tennessee Chattanooga Department of Obstetrics and Gynecology
Chattanooga, Tennessee, United States, 37403