Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07868536
PHASE2

Post-traumatic Estradiol Administration and Care Evaluation (PEACE)

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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

DRUG

17β-estradiol

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

DRUG

Placebo

Single oral dose of matching placebo administered once.