Luxor

Researchers are evaluating whether combining daily tadalafil 5 mg with on-demand sildenafil 100 mg improves erectile function in men with erectile dysfunction ED who do not respond to PDE5 inhibitors alone. This Phase 4 clinical trial aims to see if this combination leads to greater improvement in erectile function compared to on-demand sildenafil alone, while also assessing safety and tolerability in this patient group. Participants will be randomly assigned to one of two groups one receiving daily tadalafil 5 mg plus on-demand sildenafil 100 mg, and the other receiving daily placebo plus on-demand sildenafil 100 mg. The treatment period lasts 12 weeks, during which participants take the assigned medications. Follow-up assessments occur at 4, 8, and 12 weeks. This study uses a quadruple-blind design to ensure unbiased results. During the study, participants undergo baseline assessments including medical history, physical exams, and lab tests. They complete questionnaires like the International Index of Erectile Function IIEF-15 and the Erection Hardness Score EHS at baseline and follow-up visits. Researchers monitor changes in erectile function scores, patient satisfaction, and any adverse effects throughout the 12-week treatment. The main outcome is the change in IIEF-5 score from baseline to 12 weeks.