[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659706":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":60,"studyPopulation":47,"armGroups":61,"interventions":74,"overallOfficials":83,"centralContacts":89,"locations":47,"responsibleParty":97,"collaborators":47,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":47,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":121,"overallStatus":134,"whyStopped":47,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":47},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":47},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":14,"description":15,"timeFrame":16},"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",{"measure":18,"description":19,"timeFrame":20},"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",{"measure":22,"description":23,"timeFrame":24},"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",[26,30,34,37,40,44],{"measure":27,"description":28,"timeFrame":29},"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.","Pre-dose and 90-120 minutes post-dose",{"measure":31,"description":32,"timeFrame":33},"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.","Pre-dose, 90 to 120 minutes post-dose, and Month 3",{"measure":35,"description":36,"timeFrame":33},"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.",{"measure":38,"description":39,"timeFrame":33},"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.",{"measure":41,"description":42,"timeFrame":43},"Musculoskeletal pain severity","Pain severity measured using a 0 to 10 numeric rating scale, with higher scores indicating greater pain severity. Scores and changes from baseline will be compared between treatment groups.","Baseline, Week 2, Week 6, and Month 3",{"measure":45,"description":46,"timeFrame":43},"Posttraumatic stress disorder symptom severity (PCL-5)","Posttraumatic stress symptoms measured using the 20-item PTSD Checklist for DSM-5 (PCL-5). Total scores range from 0-80, with higher scores indicating greater symptom severity. Scores and changes from baseline will be compared between treatment groups.",null,{"allocation":49,"interventionModel":50,"interventionModelDescription":51,"primaryPurpose":52,"observationalModel":47,"timePerspective":47,"maskingInfo":53},"RANDOMIZED","PARALLEL","Arm 1: Single oral 6 mg dose of 17β-estradiol (E2) administered within 120 hours of sexual assault\n\nArm 2: Single oral dose of matching placebo administration within 120 hours of sexual assault","PREVENTION",{"masking":54,"maskingDescription":47,"whoMasked":55},"QUADRUPLE",[56,57,58,59],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","One in five U.S. females experience sexual assault in their lifetime, and CMSP and PTSD are common, costly, and difficult-to-treat outcomes. Despite the substantial public health burden of these conditions, few therapeutics exist to prevent CMSP or PTSD after SA. Preclinical and observational studies suggest that early administration of 17β-estradiol (E2) following traumatic stress may reduce the risk of developing CMSP and PTSD, with evidence indicating that the timing of E2 exposure relative to the traumatic event is critical. However, no randomized clinical trial has yet evaluated whether early E2 administration can prevent these outcomes following SA.\n\nTo address this gap, this pilot, randomized, double-blind, placebo-controlled trial will enroll 30 individuals assigned female at birth, aged 18 to 45 years, who experienced SA within the prior 120 hours. After screening and confirmation of eligibility, participants will be randomized 1:1 to receive either a single oral 6 mg dose of encapsulated E2 (three 2 mg tablets) or an identical placebo within 120 hours of the SA.\n\nBlood samples will be collected immediately before study drug administration and again 90 to 120 minutes afterward to assess circulating E2, cortisol, inflammatory mediators (including IL-6, IL-8, IFN-γ, IL-10, and TNF-α), and RNA expression. Participants will complete standardized assessments of pain, PTSD symptoms, and related clinical outcomes at baseline and at Week 2, Week 6, and Month 3 following enrollment. The Month 3 visit will include a final blood collection.\n\nThe primary objectives of this pilot study are to evaluate the feasibility, acceptability, and tolerability of administering early E2 following SA. Secondary and exploratory objectives include characterizing the biological response to E2 administration and obtaining preliminary estimates of its effects on CMSP and PTSD symptoms. Findings from this study will inform the design and implementation of a future fully powered efficacy trial.\n\nThe selected E2 dose is based on observational findings demonstrating that peritraumatic circulating E2 concentrations above approximately 100 pg\u002FmL are associated with a lower risk of CMSP and PTSD, together with the established safety profile of comparable oral E2 doses in other clinical settings.",[62,68],{"label":63,"type":64,"description":65,"interventionNames":66},"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.",[67],"Drug: 17β-estradiol",{"label":69,"type":70,"description":71,"interventionNames":72},"Placebo","PLACEBO_COMPARATOR","Participants receive a single oral dose of matching placebo administered within 120 hours of sexual assault.",[73],"Drug: Placebo",[75,80],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":47},"DRUG","17β-estradiol","Single oral 6 mg dose micronized 17β-estradiol administered once.",[63],{"type":76,"name":69,"description":81,"armGroupLabels":82,"otherNames":47},"Single oral dose of matching placebo administered once.",[69],[84,87],{"name":85,"affiliation":5,"role":86},"Sarah Linnstaedt, PhD","PRINCIPAL_INVESTIGATOR",{"name":88,"affiliation":5,"role":86},"Jennifer Tang, MD, MSCR",[90,94],{"name":85,"role":91,"phone":92,"phoneExt":47,"email":93},"CONTACT","984-746-4884","sarah_linnstaedt@med.unc.edu",{"name":95,"role":91,"phone":92,"phoneExt":47,"email":96},"Dasani Del Rosario, BS","peace_project@med.unc.edu",{"type":86,"investigatorFullName":85,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"Associate Professor of Anesthesiology","100659706","phase-2-post-traumatic-estradiol-administration-and-care-evaluation-peace-100659706",false,"NCT07868536","Post-traumatic Estradiol Administration and Care Evaluation (PEACE)","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","PEACE","Inclusion Criteria:\n\n* Aged 18 to 45 years\n* Assigned female at birth\n* Experienced a sexual assault within the previous 120 hours and able to complete an in-person study visit within 120 hours of the assault\n* Able to read and speak English\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Pregnant or currently breastfeeding\n* Currently taking an estrogen-containing medication\n* Current or prior diagnosis of hypertension\n* Use of anticoagulant medications (e.g. aspirin, heparin, warfarin, enoxaparin, dalteparin, tinzaparin, apixaban, rivaroxaban, dabigatran, edoxaban)\n* Current or prior cardiomyopathy; history of heart attack or heart valve disease\n* History of deep venous thrombosis or pulmonary embolism, or genetic predisposition to clots (thrombophilia)\n* Sickle cell disease\n* History of stroke\n* Migraines with aura\n* Vascular disease due to diabetes, or diabetes of more than 20 years duration\n* Chronic kidney disease (including nephrotic syndrome or dialysis)\n* Acute hepatitis; history of liver tumors\n* History of cholestasis (unless pregnancy-related only)\n* Gallbladder disease (unless treated by cholecystectomy)\n* History of systemic lupus erythematosus\n* History of breast or endometrial cancer\n* Opioid use exceeding 30 mg daily oral morphine equivalents per day\n* Smokes more than 15 cigarettes per day","FEMALE","18 Years","45 Years",{"count":111,"type":112},30,"ESTIMATED","INTERVENTIONAL",[115],"PHASE2","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.",[118,119,120],"Chronic Musculoskeletal Pain","Sexual Assault","Posttraumatic Stress Disorder (PTSD)",[77,122,123,124,125,126,127,128,129,130,131,132,133],"estradiol","estrogen","sexual assault","chronic musculoskeletal pain","chronic pain","trauma","traumatic stress","PTSD","posttraumatic stress disorder","secondary prevention","pain prevention","women's health","NOT_YET_RECRUITING","2026-10-05",{"date":137,"type":138},"2026-10-09","ACTUAL",{"date":140,"type":112},"2026-09-28",{"date":142,"type":112},"2028-07-31",{"name":5,"class":6}]