Post-traumatic Estradiol Administration and Care Evaluation (PEACE)

NCT07868536 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 24-2724
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Musculoskeletal Pain; Sexual Assault; Posttraumatic Stress Disorder (PTSD)

Keywords

17β-estradiol; estradiol; estrogen; sexual assault; chronic musculoskeletal pain; chronic pain; trauma; traumatic stress; PTSD; posttraumatic stress disorder; secondary prevention; pain prevention; women's health

Outcome Measures

Primary Outcomes (4)

• Enrollment feasibility

  Number and proportion of eligible individuals who complete the Screening Consent and are enrolled in the study.

  Throughout the recruitment period, up to 18 months

• Participant retention at Month 3

  Proportion of enrolled participants who complete the Month 3 in-person visit, including final blood collection and study questionnaires. The prespecified retention target is at least 80%.

  3 months after study-drug administration

• Acceptability of the study intervention

  Participant-reported acceptability of the study intervention, assessed using items from the Medication Acceptability Questionnaire, including overall acceptability and willingness to recommend the intervention to others.

  Enrollment Visit, following study drug administration, through Month 3

• Tolerability of the study intervention

  Number and proportion of participants reporting side effects or adverse events following study drug administration.

  Study drug administration through Month 3

Secondary Outcomes (6)

• Plasma 17β-estradiol concentration

  Pre-dose and 90-120 minutes post-dose

• Plasma cortisol concentration

  Pre-dose, 90 to 120 minutes post-dose, and Month 3

• Plasma inflammatory mediator concentrations

  Pre-dose, 90 to 120 minutes post-dose, and Month 3

• RNA expression

  Pre-dose, 90 to 120 minutes post-dose, and Month 3

• Musculoskeletal pain severity

  Baseline, Week 2, Week 6, and Month 3

Study Arms (2)

17β-Estradiol (E2)

EXPERIMENTAL

Participants receive a single oral 6 mg dose of micronized 17β-estradiol (three encapsulated 2 mg tablets) administered within 120 hours of sexual assault.

Drug: 17β-estradiol

Placebo

PLACEBO COMPARATOR

Participants receive a single oral dose of matching placebo administered within 120 hours of sexual assault.

Drug: Placebo

Interventions

17β-estradiol DRUG

Single oral 6 mg dose micronized 17β-estradiol administered once.

17β-Estradiol (E2)

Placebo DRUG

Single oral dose of matching placebo administered once.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 45 years
• Assigned female at birth
• Experienced a sexual assault within the previous 120 hours and able to complete an in-person study visit within 120 hours of the assault
• Able to read and speak English
• Able to provide informed consent

You may not qualify if:

• Pregnant or currently breastfeeding
• Currently taking an estrogen-containing medication
• Current or prior diagnosis of hypertension
• Use of anticoagulant medications (e.g. aspirin, heparin, warfarin, enoxaparin, dalteparin, tinzaparin, apixaban, rivaroxaban, dabigatran, edoxaban)
• Current or prior cardiomyopathy; history of heart attack or heart valve disease
• History of deep venous thrombosis or pulmonary embolism, or genetic predisposition to clots (thrombophilia)
• Sickle cell disease
• History of stroke
• Migraines with aura
• Vascular disease due to diabetes, or diabetes of more than 20 years duration
• Chronic kidney disease (including nephrotic syndrome or dialysis)
• Acute hepatitis; history of liver tumors
• History of cholestasis (unless pregnancy-related only)
• Gallbladder disease (unless treated by cholecystectomy)
• History of systemic lupus erythematosus

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Related Publications (4)

• 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.

  PMID: 27777223 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.

  PMID: 22925127 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.

  PMID: 34028234 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.

  PMID: 39287098 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Chronic Pain; Wounds and Injuries

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Sarah Linnstaedt, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Jennifer Tang, MD, MSCR

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Linnstaedt, PhD

CONTACT

984-746-4884; sarah_linnstaedt@med.unc.edu

Dasani Del Rosario, BS

CONTACT

984-746-4884; peace_project@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Model Details: Arm 1: Single oral 6 mg dose of 17β-estradiol (E2) administered within 120 hours of sexual assault Arm 2: Single oral dose of matching placebo administration within 120 hours of sexual assault

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within approximately 6 months of publication of the primary study results.
• Access Criteria: Requests for data access will be reviewed by the study investigators on a case-by-case basis. Qualified researchers with a methodologically sound proposal may be granted access following approval by the study investigators and, as applicable, the Institutional Review Board (IRB). Data will be shared through secure methods and may require execution of a data use agreement in accordance with institutional policies.