[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643499":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":24,"locations":28,"responsibleParty":49,"collaborators":24,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":24,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":75,"overallStatus":31,"whyStopped":24,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Northwestern University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fulvestrant 250 mg","EXPERIMENTAL","Participants will receive fulvestrant 250 mg intramuscularly on Days 1, 15, and 29, then monthly for 6 months.",[13],"Drug: Fulvestrant",{"label":15,"type":10,"description":16,"interventionNames":17},"Anastrozole 5 mg","Participants will receive anastrozole 5 mg orally once daily for 6 months.",[18],"Drug: Anastrazole",[20,25],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG","Fulvestrant",[9],null,{"type":21,"name":26,"description":16,"armGroupLabels":27,"otherNames":24},"Anastrazole",[15],[29],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Northwestern Memorial Hospital","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-87.65005,41.85003,{"lat":41,"lon":40},[44],{"name":45,"role":46,"phone":47,"phoneExt":24,"email":48},"Nancy Ly, MD","CONTACT","3126956868","nancy.ly@nm.org",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Megan Melland-Smith","Co-Investigator","100643499","phase-1-reversing-inguinal-hernia-trial-the-evaluation-of-sex-hormones-to-reverse-inguinal-hernias-in-males-100643499",false,"NCT07604272","Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males","Reversing InGuinal Hernia Trial (RIGHT Trial): The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males","RIGHT","Inclusion Criteria:\n\n* Male sex\n* Age ≥ 50 years at time of enrollment\n* Symptomatic unilateral inguinal hernia confirmed on physical examination\n* Hernia visible \u002F confirmed on groin ultrasound\n* Non-recurrent inguinal hernia (primary hernia only)\n* Willing and able to provide written informed consent\n* Able and willing to comply with all protocol-required visits, laboratory assessments, imaging, and follow-up\n* Willing to use contraception and avoid fathering a child during study participation and for 12 months after last dose\n* Willing to be counseled regarding vitamin D and calcium supplementation Bone safety mitigation measure per PIND response.\n\nExclusion Criteria:\n\nHernia Characteristics\n\n* Scrotal hernia (any)\n* Bilateral inguinal hernia\n* Recurrent inguinal hernia (prior repair at same site)\n\nRenal \\& Hepatic\n\n* Clinically significant renal dysfunction judged by investigator to increase study risk\n* Clinically significant hepatic dysfunction at baseline\n\nHematologic\n\n■ Clinically significant baseline hematologic abnormality (including elevated hematocrit or polycythemia)\n\nUrologic \u002F Prostate\n\n* Symptomatic benign prostatic hyperplasia (BPH) requiring active medical or procedural treatment\n* Clinically significant untreated prostate disease\n\nSkeletal \u002F Bone\n\n* Baseline osteoporosis (T-score ≤ -2.5 on DEXA at any site)\n* Recent fragility fracture (within prior 12 months or as judged by investigator)\n* Other clinically significant skeletal vulnerability judged to increase risk from estrogen suppression\n\nImmunosuppression ■ Active immunosuppression (e.g., systemic corticosteroids, biologic agents, post-transplant regimens)\n\nPsychiatric\n\n■ Unstable or uncontrolled psychiatric illness that, in the investigator's judgment, would interfere with safe study participation\n\nReproductive \u002F Fertility ■ Actively pursuing fertility or planning conception during study participation\n\nPrior \u002F Concomitant Therapy\n\n* Current use of androgen replacement therapy, exogenous estrogen, or other endocrine-active agents that would confound study interpretation\n* Prior or current use of aromatase inhibitor or selective estrogen receptor modulator \u002F degrader within 6 months of enrollment\n\nGeneral\n\n■ Any other clinically significant medical condition, laboratory abnormality, or circumstance that, in the investigator's judgment, would place the participant at unacceptable risk or compromise study integrity","MALE","50 Years",{"count":64,"type":65},30,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","This is a prospective, single-center, three-arm Phase 1 safety and feasibility trial evaluating anti-estrogen therapy in men age 50 years and older with symptomatic unilateral inguinal hernias. Participants will be randomized to receive fulvestrant 250 mg intramuscularly, fulvestrant 500 mg intramuscularly, or letrozole 5 mg orally for 6 months. The study will evaluate safety, tolerability, feasibility, hormone changes, hernia size, patient-reported outcomes, bone density, and imaging-based hernia classification.",[71,72,73,74],"Inguinal Hernia Unilateral","Inguinal Hernia Bilateral","Inguinal Hernia Without Obstruction or Gangrene","Inguinal Hernia, Without Mention of Obstruction or Gangrene",[76,77,78,79,80,81,82,83,84,85,86,87,88],"inguinal hernia","hernia","fulvestrant","letrozole","anti-estrogen therapy","aromatase inhibitor","estrogen receptor","ESR1","male inguinal hernia","hormonal therapy","fibrosis","hernia prevention","hernia regression","2026-06-24",{"date":91,"type":92},"2026-06-26","ACTUAL",{"date":94,"type":65},"2026-07-01",{"date":96,"type":65},"2028-06",{"name":5,"class":6},1]