This trial is active, not recruiting.

Condition pain
Treatments lidocaine, placebo
Sponsor University of Pittsburgh
Collaborator Society of Family Planning
Start date June 2012
End date May 2013
Trial size 64 participants
Trial identifier NCT01534520, SFP-RBR001


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Placebo Comparator)
Intravaginal insertion of 5mL placebo gel
KY Jelly
Intravaginal insertion of 5mL 2% lidocaine gel
lidocaine Lidocaine Jelly
Intravaginal insertion of 5mL 2% lidocaine gel

Primary Outcomes

To assess change in pain from baseline to IUD insertion as determined by 100mm visual analog scale (VAS) for self-administered intravaginal 2% lidocaine gel as compared to placebo gel.
time frame: One year

Secondary Outcomes

To evaluate patient acceptability of self-inserting the intravaginal study gel prior to IUD
time frame: One year
To measure ease of IUD insertion as reported by physicians
time frame: One year

Eligibility Criteria

Female participants from 14 years up to 55 years old.

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

Additional Information

Official title Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women: a Randomized Controlled Trial
Principal investigator Rachel B Rapkin, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by University of Pittsburgh.