NCT02352714: SOPHI

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

Completed Phase 4 Last updated 12 September 2018

What this trial tests

Phase 4 trial testing Paracervical Nerve Block in Pain in 98 participants. Completed in 1 July 2016.

Timeline

1 January 2015

Primary endpoint
1 July 2016

1 July 2016

Quick facts

Lead sponsor	Children's Hospital of Philadelphia
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	98
Start date	1 January 2015
Primary completion	1 July 2016
Estimated completion	1 July 2016
Sites	3 locations across United States

Drugs / interventions tested

• Paracervical Nerve Block — full drug profile →
• Sham Paracervical Block — full drug profile →

Conditions studied

• Pain — all drugs for Pain →

Sponsor

Children's Hospital of Philadelphia

Who can join

Adults 14 to 22, female only, with Pain. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Self-reported pain
  Time frame: Intraoperative (At the time of insertion of the IUS)
  The primary outcome will be assessed using a visual analogue scale (VAS). Assessment will occur at the time of the insertion of the IUS device. The IUS will be placed according to manufacturer's recommendation.

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Reducing Pain During Intrauterine Device Insertion: A Randomized Controlled Trial in Adolescents and Young Women.
   Akers AY, Steinway C, Sonalkar S, Perriera LK, et al · · 2017 · cited 50× · PMID 28885425 · DOI 10.1097/aog.0000000000002242
2. Satisfaction With the Intrauterine Device Insertion Procedure Among Adolescent and Young Adult Women.
   Akers AY, Harding J, Perriera LK, Schreiber C, et al · · 2018 · cited 21× · PMID 29742656 · DOI 10.1097/aog.0000000000002596
3. Personalized medicine for pathological circadian dysfunctions.
   Skelton RL, Kornhauser JM, Tate BA. · · 2015 · cited 5× · PMID 26150790 · DOI 10.3389/fphar.2015.00125
4. Intrauterine Device Insertion Procedure Duration in Adolescent and Young Adult Women.
   O'Flynn O'Brien KL, Akers AY, Perriera LK, Schreiber CA, et al · · 2019 · cited 4× · PMID 30633980 · DOI 10.1016/j.jpag.2019.01.002