Post-traumatic Estradiol Administration and Care Evaluation (PEACE)

Summary

This pilot randomized, double-blind, placebo-controlled trial evaluates the feasibility, acceptability, and tolerability of administering a single 6 mg oral dose of 17β-estradiol (E2) to individuals assigned female at birth who have experienced a sexual assault (SA) within the previous 120 hours. Thirty participants aged 18 to 45 years will be randomized 1:1 to receive either E2 or an identical-appearing placebo and followed for three months with blood collection and standardized assessments. The study will evaluate recruitment, enrollment, retention, biological responses, and preliminary clinical outcomes, including chronic musculoskeletal pain (CMSP) and posttraumatic stress disorder (PTSD), to inform the design of a future fully powered efficacy trial.

Timeline

Start

2026-09-28

Primary completion

2028-03-31

Completion

2028-07-31

Publications

• Background Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
• Background Ferree NK, Wheeler M, Cahill L. The influence of emergency contraception on post-traumatic stress symptoms following sexual assault. J Forensic Nurs. 2012 Sep;8(3):122-30. doi: 10.1111/j.1939-3938.2012.01134.x. Epub 2012 Mar 5.
• Background Linnstaedt SD, Mauck MC, Son EY, Tungate AS, Pan Y, Rueckeis C, Yu S, Lechner M, Datner E, Cairns BA, Danza T, Velilla MA, Pearson C, Shupp JW, Smith DJ, McLean SA. Peritraumatic 17beta-estradiol levels influence chronic posttraumatic pain outcomes. Pain. 2021 Dec 1;162(12):2909-2916. doi: 10.1097/j.pain.0000000000002282.
• Background Son E, Gaither R, Lobo J, Zhao Y, McKibben LA, Arora R, Albertorio-Saez L, Mickelson J, Wanstrath BJ, Bhatia S, Stevens JS, Jovanovic T, Koenen K, Kessler R, Ressler K, Beaudoin FL, McLean SA, Linnstaedt SD. Further evidence that peritraumatic 17beta-estradiol levels influence chronic posttraumatic pain outcomes in women, data from both humans and animals. Pain. 2025 Apr 1;166(4):812-823. doi: 10.1097/j.pain.0000000000003408. Epub 2024 Sep 13.

Drugs

Indications