Overview
Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women
Status:
Completed
Completed
Trial end date:
2013-05-01
2013-05-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
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.Phase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
University of PittsburghCollaborator:
Society of Family PlanningTreatments:
Lidocaine
Criteria
Inclusion criteria:- 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
Exclusion criteria:
- 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