[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566004":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":37,"centralContacts":41,"locations":50,"responsibleParty":71,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":30,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":30,"enrollmentInfo":87,"targetDuration":30,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":53,"whyStopped":30,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Charitable Union for the Research and Education of Peyronie's Disease","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Primary Cohort","EXPERIMENTAL","Men would receive 4 series of CCH injections:\n\n* Administered on back-to-back days\n* 0.9 mg administered with each series, diluted to 0.8 mL\n* Mild in-office modeling performed on treatment day 2 of each series\n* Wraps applied 2-4 full-time and 2-4 part-time days\n* Sildenafil 25 mg nightly and Restorex beginning treatment day 2 (sildenafil) or 3 (Restorex - 30 min\u002Fday) until 6 weeks after final injection of the final series.\n\nNote that men may stop sooner if they are satisfied before completing the 4 series. If the patient is not satisfied with outcomes by the end of the 4th series, they would be permitted to enter the 'salvage' phase of the treatment protocol.\n\n* Performed 9-12 months after the 4th series of injections.\n* The technique would incorporate more aggressive, in-office modeling.\n* Men would receive up to two additional series per this protocol.",[13,14,15],"Drug: Collagenase Clostridium Histolyticum","Device: RestoreX","Drug: Sildenafil",[17,25,31],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Collagenase Clostridium Histolyticum","4 Series given to each participant, 6 weeks apart. Medication administered on back-to-back days. If failing to achieve an adequate response, men may receive up to 2 additional series 9-12 months after the 4th series.\n\nTotal of 0.9 mg administered with each series, diluted to 0.8 mL",[9],[23,24],"Xiaflex","CCH",{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","RestoreX","Restorex initiated beginning on post-injection day 3 or as soon as tolerated - 30 min daily, continuing until 6 weeks after final injection of the final CCH series.",[9],null,{"type":18,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Sildenafil","Men will be prescribed sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series.",[9],[36],"Viagra",[38],{"name":39,"affiliation":5,"role":40},"Landon Trost, MD","PRINCIPAL_INVESTIGATOR",[42,46],{"name":39,"role":43,"phone":44,"phoneExt":30,"email":45},"CONTACT","801-655-0015","email@mfp.clinic",{"name":47,"role":43,"phone":48,"phoneExt":30,"email":49},"Holli Burgon","801-691-4714","burgon.holli@menshealthstudies.com",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Male Fertility and Peyronie's Clinic","RECRUITING","Orem","Utah","84057","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-111.69465,40.2969,{"lat":63,"lon":62},[66,67,70],{"name":39,"role":43,"phone":44,"phoneExt":30,"email":45},{"name":68,"role":43,"phone":44,"phoneExt":30,"email":69},"Jesse Labbe, PhD","labbe.jesse@menshealthstudies.com",{"name":39,"role":40,"phone":30,"phoneExt":30,"email":30},{"type":40,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Landon Trost","Principal Investigator, MD",[75],{"name":76,"class":77},"Endo USA Inc., a Keenova Therapeutics Company","INDUSTRY","100566004","phase-4-delayed-dose-collagenase-clostridium-histolyticum-cch-protocol-for-men-with-peyronies-disease-100566004",false,"NCT06649539","Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease","Efficacy of a Step-wise Protocol in Optimizing CCH Outcomes in Men With Peyronie's Disease","Inclusion Criteria:\n\n* Men with Peyronie's Disease\n* Older than 18 years old\n* Curvature ≥30 degrees\n* Ability to achieve an erection satisfactory for intercourse with or without phosphodiesterase-5 (PDE5) inhibitors\n* The patient exhibits a palpable plaque consistent with Peyronie's Disease\n* For partners, the only inclusion criteria is being willing to complete a questionnaire\n\nExclusion Criteria:\n\n* Prior surgical treatment on the penis (other than circumcision)\n* Prior treatment with CCH injections\n* Any contraindications to CCH - as determined by the PI","ALL","18 Years",{"count":88,"type":89},40,"ESTIMATED","INTERVENTIONAL",[92],"PHASE4","Our team has previously demonstrated efficacy in performing a novel collagenase Clostridium histolyticum (CCH) injection protocol in men who previously failed to achieve a response to an initial 4 series of CCH.\n\nThe objective of the current study is to evaluate a protocol that incorporates limited in-office modeling for up to 4 series, followed by up to 2 additional salvage series to determine safety and efficacy compared to historical data.\n\nParticipants will receive up to 4 series of CCH injections using our previously published protocol, with mild in-office modeling. CCH injections are given on back-to back days, after which they are counseled to utilize Restorex and sildenafil daily, as instructed. Patients will undergo mild in-office modeling on day 2.\n\nThe sexual partners of study participants will also be invited to enroll in the study and will complete non-validated questionnaires detailing their level of support for the patient's treatment.",[95],"Peyronie Disease",[97,98,99,23,100,101],"collagenase clostridium histolyticum","curvature","Restorex","traction","salvage","2025-02-12",{"date":104,"type":105},"2025-02-13","ACTUAL",{"date":107,"type":105},"2024-10-11",{"date":109,"type":89},"2029-10",{"name":5,"class":6},1]