Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women
Completed · Not applicable · Has a placebo group
Conditions studied: Pain
In brief
This study is designed to evaluate if self-inserted intravaginal 2% lidocaine gel is effective at decreasing pain during intrauterine device insertion in nulliparous women.
Key facts
- Study ID
- NCT01534520
- Run by
- University of Pittsburgh
- People needed
- 61
- Starts
- 2012-06-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2016-12-22
Who can join
Age: 14 and older, up to 55. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age
- Desires insertion of either levonorgestrel-releasing IUD (LNG-IUD) or copper T380A IUD (Cu-IUD)
- No history of pregnancy in the last 6 weeks
- Able to provide written informed consent in English and comply with all study procedures
You may not qualify if…
- Known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics
- Prior failed IUD insertion
- Prior IUD use
- Use of narcotic or benzodiazepine medication within the last 24 hours
- U.S. Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for use of an IUD
- Positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period
Where it is running
- Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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