N/A Completed N=59 Randomized Triple-blind Treatment

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

Postoperative Pain

Source: ClinicalTrials.gov NCT01534520 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2016

Primary outcomePrimary: Change in Pain From Baseline to IUD Insertion — 61; 68 change in visual analog scale score

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pain From Baseline to IUD Insertion	61; 68	—
SECONDARY To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD	29; 29	—
SECONDARY Percentage of IUDs Considered by Physicians Easy to Insert	87; 64	—
SECONDARY Need for Pain Medication up to 7 Days	24; 27	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01534520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.