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

Intrauterine devices (IUDs) are among the most effective forms of reversible contraception.
Numerous studies demonstrate their safety and efficacy in nulliparous women, however, uptake
of IUDs in this group is low. One of the major barriers to women obtaining IUDs is fear of
pain during insertion, as studies do demonstrate that nulliparous women experience more pain
than parous women during IUD insertion. Studies evaluating various methods for pain
control during IUD insertion have shown conflicting results, leaving the question unanswered
as to what is the best method to decrease pain during IUD insertion.

This study aims to evaluate a novel approach to pain control by having women self-insert
lidocaine gel into the vagina at least 5 minutes prior to IUD insertion. This will overcome
some of the barriers from other studies where there may not have been ample time for the
lidocaine to take effect, while at the same time eliminating the need for women to have
multiple speculum exams. Although this is a novel approach to administering an anesthetic,
we believe women will be interested in any intervention that may potentially alleviate pain
during IUD insertion.

If this study does demonstrate that pain is decreased with self-inserted lidocaine compared
to placebo gel, this will potentially eliminate one large barrier to nulliparous women
receiving IUDs. Increased uptake of highly effective contraception in nulliparous women is
just one of the many steps necessary towards decreasing unintended pregnancy.

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