CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 98 enrolled
Drug / intervention
Paracervical Nerve Block +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/NCT02352714
NCT02352714Phase 4Completed
CompareCT.gov

Study of Pain Control With Hormonal IUS Insertion (SOPHI Study)

Children's Hospital of Philadelphia·interventional·Posted Feb 2, 2015·Updated Sep 14, 2018

In Brief

A Phase 4 clinical trial evaluating Paracervical Nerve Block and Sham Paracervical Block for Pain. Completed, enrolled 98 participants across 3 sites.

Detailed Summary

This study aims to compare pain during insertion of the Skyla® IUS using a 100mm visual analog scale (VAS) among 92 young women aged 14 to 22 years randomized to receive a paracervical (n=46) block versus a sham paracervical block (n=46).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
CollaboratorsBayer, University of Pennsylvania

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2, 2015
Enrollment StartJan 1, 2015
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.4 years ago

Interventions

Paracervical Nerve Blockdrug

Block randomization to receive lidocaine paracervical nerve block vs sham cervical block

Sham Paracervical Blockdrug

Block randomization to receive lidocaine paracervical nerve block vs sham cervical block