Topical Lidocaine for Pain Control With Intrauterine Device (IUD) Insertion

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Pain

In brief

Intrauterine contraception is a very effective, long term, reversible form of birth control, and is increasingly used in young, nulliparous patients. However, there is potential for pain with insertion of an Intrauterine Device (IUD) - particularly in patients without a previous history of vaginal delivery. The potential pain associated with insertion is often a significant barrier for patients when choosing and IUD for contraception. Several methods of pain control have been studied, but none have been shown to reduce pain at time of insertion. Our research question is to determine if 2% topical lidocaine gel, instilled into the cervical canal, will reduce maximum pain at time of insertion of a popular IUD (Mirena Intrauterine System) in young, nulliparous patients. This will be studied in a randomized, double-blind placebo-controlled trial.

Key facts

Study ID

NCT01445756

Run by

University of Wisconsin, Madison

People needed

40

Starts

2010-07-01

Expected to finish

2011-06-01

Last updated by the study team

2014-08-26

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Must be at least 18 years old

You may not qualify if…

• Age <18
• Non-English speaking
• Illiterate
• History of pregnancy with delivery >20 weeks
• History of prior IUD insertion or attempt

Where it is running

• University Health Services Women's Care Clinic — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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