[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07636161":3,"trial-entities:NCT07636161":99,"trial-summary:NCT07636161":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":42,"secondary_outcomes":47,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":73,"locations":75,"central_contacts":91,"overall_officials":93,"references":97,"see_also_links":98},"NCT07636161","20260268","PLEASURE (Pleasing Lovers, Efficacy, Arousal, Satisfaction, and Uptake Research on Eroxon)","PLEASURE (Pleasing Lovers, Efficacy, Arousal, Satisfaction, and Uptake Research on Eroxon): A Pilot Randomized Trial of Eroxon® Gel as an Adjunct to Tadalafil in Young Men With Diabetes-Associated Erectile Dysfunction","NOT_YET_RECRUITING","2027-09","2026-05","2026-06-09","2026-09","University of Miami","OTHER",false,"The purpose of this research study is to look at whether Eroxon® gel when used together with tadalafil, may help improve erectile function in men ages 18 to 40 who have type 2 diabetes.",null,[19,20],"Type 2 Diabetes","Type 2 Diabetes (T2DM)",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE4",{"count":27,"type":28},30,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","Eroxon®","Participants will receive a 12-week supply of Eroxon® and will be instructed to apply the gel prior to each sexual encounter as directed at enrollment.",[35],"Standard of Care (Tadalafil) + Eroxon® Gel Group",{"type":37,"name":38,"description":39,"armGroupLabels":40},"DRUG","tadalafil","Tadalafil is administered as standard of care at dose and schedule determined by the treating clinician.",[35,41],"Tadalafil (Control) Group",[43],{"measure":44,"description":45,"timeFrame":46},"Change in Erectile Functioning","Erectile function assessed using the International Index of Erectile Function-5 (IIEF-5), a validated 5-item patient-reported questionnaire. Total scores range from 5 to 25, with higher scores indicating better erectile function.","Baseline to Week 12",[48,51],{"measure":49,"description":50,"timeFrame":46},"Change in Patient Adherence","Patient adherence assessed using the Medication Adherence Report Scale-5 (MARS-5), a validated five-item self-report questionnaire measuring both intentional and unintentional non-adherence. Each item is scored on a 5-point Likert scale, with total scores ranging from 5 to 25, and higher scores indicating better adherence.",{"measure":52,"description":53,"timeFrame":46},"Change in Partner Acceptability","Partner acceptability assessed using the Sexual Life (ISL) scale, a validated 11-item questionnaire evaluating satisfaction and acceptability related to sexual activity. Each item is scored on a 5-point Likert scale, with total scores ranging from 5 to 25, with higher scores indicating greater partner satisfaction and acceptability.","MALE","18 Years","40 Years",{"inclusion":58,"exclusion":66,"raw_text":72},[59,60,61,62,63,64,65],"Male sex at birth","Age 18-40 years","Diagnosis of type 2 diabetes mellitus","Diagnosis of erectile dysfunction","Currently prescribed tadalafil","Have a sexual partner willing to complete a survey","Ability to provide informed consent",[67,68,69,70,71],"Type 1 diabetes mellitus","Severe psychiatric illness that would impair participation","Use of nitrates or contraindications to sexual activity","Known allergy to Eroxon® gel components","Participation in another interventional sexual health study","Inclusion Criteria:\n\n* Male sex at birth\n* Age 18-40 years\n* Diagnosis of type 2 diabetes mellitus\n* Diagnosis of erectile dysfunction\n* Currently prescribed tadalafil\n* Have a sexual partner willing to complete a survey\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Severe psychiatric illness that would impair participation\n* Use of nitrates or contraindications to sexual activity\n* Known allergy to Eroxon® gel components\n* Participation in another interventional sexual health study",[74],"ADULT",[76],{"facility":77,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":88},"Don Soffer Clinical Research Building","Miami","Florida","33136","United States",[83],{"name":84,"role":85,"phone":86,"email":87},"Ashley Gray","CONTACT","786-909-3719","ajg2940@med.miami.edu",{"lat":89,"lon":90},25.77427,-80.19366,[92],{"name":84,"role":85,"phone":86,"email":87},[94],{"name":95,"affiliation":13,"role":96},"Sonjia Kenya, E.D","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":100,"biomarkers":102},[101],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]