Overview

Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women

Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
0
Participant gender:
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/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Pittsburgh
Collaborator:
Society of Family Planning
Treatments:
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