Health TrialsbyHealthPanel

Post-traumatic Estradiol Administration and Care Evaluation (PEACE)

ConditionsChronic Musculoskeletal PainSexual AssaultPosttraumatic Stress Disorder (PTSD)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 17β-estradiol

    Drug

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

  • Placebo

    Drug

    Single oral dose of matching placebo administered once.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: 17β-Estradiol (E2)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Enrollment feasibility

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

Time frame
Throughout the recruitment period, up to 18 months
2

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%.

Time frame
3 months after study-drug administration
3

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.

Time frame
Enrollment Visit, following study drug administration, through Month 3
4

Tolerability of the study intervention

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

Time frame
Study drug administration through Month 3

Secondary outcomes

1

Plasma 17β-estradiol concentration

Change in plasma 17β-estradiol concentration from pre-dose to 90-120 minutes after study-drug administration, compared between treatment groups.

Time frame
Pre-dose and 90-120 minutes post-dose
2

Plasma cortisol concentration

Change in plasma cortisol concentration from pre-dose to 90-120 minutes after study-drug administration and differences between treatment groups at Month 3.

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

Plasma inflammatory mediator concentrations

Changes in plasma concentrations of IL-6, IL-8, IFN-γ, IL-10 and TNF-α from pre-dose to 90-120 minutes after study-drug administration and differences between treatment groups at Month 3.

Time frame
Pre-dose, 90 to 120 minutes post-dose, and Month 3
4

RNA expression

Changes in peripheral-blood RNA expression following study-drug administration, including differences in RNA expression profiles between treatment groups 90-120 minutes after study-drug administration and longitudinal changes from enrollment to Month-3.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: