[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588649":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":56,"collaborators":59,"id":63,"slug":26,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":26,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Beth Israel Deaconess Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Finasteride + Inactive Placebo Monotherapy","ACTIVE_COMPARATOR","Participants may be randomized into the Finasteride + Inactive Placebo Monotherapy arm.",[13],"Drug: Finasteride",{"label":15,"type":16,"description":17,"interventionNames":18},"Finasteride + Raloxifene Combination Therapy","EXPERIMENTAL","Participants may be randomized into the Finasteride + Raloxifene Combination Therapy arm.",[19,13],"Drug: raloxifene",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","raloxifene","Participants in the Finasteride + Raloxifene Combination Therapy Arm will receive both Finasteride and Raloxifene as their intervention.\n\nParticipants randomized to the Finasteride + Raloxifene Combination Therapy arm will self-administer finasteride at 5 mg orally\u002Fday and raloxifene at 60 mg orally\u002Fday.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Finasteride","Participants randomized to the Finasteride + Inactive Placebo Monotherapy arm will self-administer finasteride at 5 mg orally\u002Fday and placebo capsule daily.",[9,15],[32],{"name":33,"affiliation":5,"role":34},"Aria Olumi, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Yulia Mulugeta","CONTACT","617-632-8890","ymuluget@bidmc.harvard.edu",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Boston","Massachusetts","02215","United States",{"type":49,"coordinates":50},"Point",[51,52],-71.05977,42.35843,{"lat":52,"lon":51},[55],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":34,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Aria F. Olumi, MD","Chief, Division of Urology, BIDMC",[60],{"name":61,"class":62},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100588649",false,"NCT06944145","New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia","A Phase 2b Randomized, Single-Center, Double Blind, Placebo Controlled, 2-Arm Study to Investigate Orally Administered Combination Therapies (5-alpha Reductase Inhibitor + Raloxifene) Compared With Monotherapy (5-alpha Reductase Inhibitor + Placebo) in Adult Patients With Benign Prostatic Hyperplasia (BPH)","Inclusion criteria\n\n1. ≥18 yrs old on the day of study consent;\n2. Finasteride has been recommended for treatment of BPH by a physician;\n3. PSA \\\u003C20ng\u002Fml within the last six months;\n4. Willingness to maintain any current genitourinary medications (e.g., beta agonists, alpha blockers, anticholinergics);\n5. Patient is able and willing to provide written informed consent.\n\nExclusion criteria\n\n1. Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis;\n2. Previous diagnosis with any prostatic malignancy or precancerous lesions (atypical glandular foci);\n3. History of pelvic radiation;\n4. Actively receiving intravesical therapy for bladder cancer;\n5. Received treatment with any demethylating medications (azacitidine, decitabine, zebularine, guadecitabine, hydralazine);\n6. Current use of warfarin;\n7. Prior treatment with 5ARI medications (e.g., Finasteride or Dutasteride) in the last year;\n8. Diagnosed with diabetes mellitus;\n9. Diagnosed with any neurodegenerative diseases;\n10. History of allergic reaction to any intravenous (IV) iron replacement products;\n11. Currently taking cholestyramine medication;\n12. Contraindications to MRI examination, which may include:\n\n    * Cardiac pacemaker\n    * Intracranial clips, metal implants, or external clips within 10mm of the head\n    * Previous metal injury in the eye or occupation risk to ferrous metal in the eye (e.g. metalworker)\n    * Claustrophobia that cannot be managed with benzodiazepine","MALE","18 Years",{"count":72,"type":73},242,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","SRD5A2 is a critical enzyme for prostatic development and growth, and the SRD5A2 inhibitor, finasteride, is used to treat benign prostatic hyperplasia (BPH). SRD5A2 is absent in 30% of normal adult men, which explains the resistance of a subset of patients to this commonly prescribed drug. This project proposes new combination therapies (5-ARI+raloxifene) and evaluates novel non-invasive biomarkers, based on alternative pathways that lead to prostatic enlargement.",[79,80],"BPH (Benign Prostatic Hyperplasia)","Lower Urinary Track Symptoms",[82,83,28,84],"BPH","SRD5A2","LUTS","2026-03-19",{"date":87,"type":88},"2026-03-23","ACTUAL",{"date":90,"type":88},"2025-12-03",{"date":92,"type":73},"2030-08-31",{"name":5,"class":6},1]