N/A
N=59
Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01534520 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Change in Pain From Baseline to IUD Insertion — 61; 68 change in visual analog scale score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lidocaine (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- Female
- Sponsor
- University of Pittsburgh
- Primary completion
- May 2013
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 | — |
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.
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
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.