Clinical Research Directory
Browse clinical research sites, groups, and studies.
Post-traumatic Estradiol Administration and Care Evaluation (PEACE)
Sponsor: University of North Carolina, Chapel Hill
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.
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
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-09-28
Completion Date
2028-07-31
Last Updated
2026-10-09
Healthy Volunteers
No
Interventions
17β-estradiol
Single oral 6 mg dose micronized 17β-estradiol administered once.
Placebo
Single oral dose of matching placebo administered once.