Post-traumatic Estradiol Administration and Care Evaluation (PEACE)
Not yet recruitingPhase 2NCT07868536
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Pilot Randomized, Double-Blind, Placebo-Controlled Trial of Single-Dose Oral 17β-Estradiol Administered Within 120 Hours of Sexual Assault to Evaluate Feasibility, Acceptability, and Preliminary Effects on Chronic Musculoskeletal Pain and PTSD Over the Following Three Months
- Conditions
- Chronic Musculoskeletal Pain
- Sexual Assault
- Posttraumatic Stress Disorder (PTSD)
- Interventions
- Drug: 17β-estradiol
- Drug: Placebo
- Sponsor
- University of North Carolina, Chapel Hill
- Start date
- 2026-09-28
- Primary completion
- 2028-03-31
- Sex
- Female
- Age range
- from 18 Years to 45 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * History of breast or endometrial cancer * Opioid use exceeding 30 mg daily oral morphine equivalents per day * Smokes more than 15 cigarettes per day
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07868536