CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 220 enrolled
Drug / intervention
Vaginal 2% Lidocaine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02738203
NCT02738203Phase 3Completed

Self-Administered Lidocaine Gel for Pain Management With IUD Insertion: A Randomized Controlled Trial

Stanford University·interventional·Posted Apr 14, 2016·Updated Jun 6, 2019

In Brief

A Phase 3 clinical trial evaluating Vaginal 2% Lidocaine and Surgical Lubricant Jelly for IUD Insertion. Completed, enrolled 220 participants across 1 site.

Detailed Summary

For intrauterine device (IUD) insertion, currently there are no standardized clinical guidelines for pain management. The investigators aim to explore whether adequate pain relief is possible through self-administered, non-invasive means alone. Reducing pain associated with IUD insertion may benefit patients and providers. When patients are comfortable during their procedure, it is likely the provider can more quickly and with fewer complications perform the insertion. The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the standard of care pain management, no intervention, prior to IUD insertions. This is a superiority, blinded, randomized controlled trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIUD Insertion
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 14, 2016
Enrollment StartJun 1, 2016
Primary CompletionOct 19, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.2 years ago

Interventions

Vaginal 2% Lidocainedrug

Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly

Surgical Lubricant Jellydrug

Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly