[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643499":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":29,"responsibleParty":50,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":25,"enrollmentInfo":64,"targetDuration":25,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":32,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"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 and 29, then monthly for 6 months.",[13],"Drug: Fulvestrant",{"label":15,"type":10,"description":16,"interventionNames":17},"Anastrozole 1 mg","Participants will receive anastrozole 1 mg orally once daily for 6 months.",[18],"Drug: Anastrozole (ARIMIDEX™)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Fulvestrant","Participants will receive fulvestrant 250 mg intramuscularly on Days 1 and 29, then monthly for 6 months.",[9],null,{"type":21,"name":27,"description":16,"armGroupLabels":28,"otherNames":25},"Anastrozole (ARIMIDEX™)",[15],[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Northwestern Memorial Hospital","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-87.65005,41.85003,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":48,"phoneExt":25,"email":49},"Nancy Ly, MD","CONTACT","3126956868","nancy.ly@nm.org",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"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":65,"type":66},30,"ESTIMATED","INTERVENTIONAL",[69],"PHASE1","This is a prospective, single-center, two-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 or anastrozole 1 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.",[72,73,74,75],"Inguinal Hernia Unilateral","Inguinal Hernia Bilateral","Inguinal Hernia Without Obstruction or Gangrene","Inguinal Hernia, Without Mention of Obstruction or Gangrene",[77,78,79,80,81,82,83,84,85,86,87,88,89],"inguinal hernia","hernia","fulvestrant","anti-estrogen therapy","aromatase inhibitor","estrogen receptor","ESR1","male inguinal hernia","hormonal therapy","fibrosis","hernia prevention","hernia regression","anastrozole","2026-07-30",{"date":92,"type":93},"2026-08-03","ACTUAL",{"date":95,"type":93},"2026-07-31",{"date":97,"type":66},"2028-07",{"name":5,"class":6},1]