DOUBLE-BLIND MULTICENTER STUDY COMPARING ALPROSTADIL ALPHA-CYCLODEXTRIN WITH MOXISYLYTE CHLORHYDRATE IN PATIENTS WITH CHRONIC ERECTILE DYSFUNCTION

Purpose: We compared the efficacy and safety of alprostadil alpha-cycl odextrin and moxisylyte chlorhydrate to induce erections adequate for sexual intercourse in a prospective, randomized, parallel double-blind study in patients with erectile dysfunction. Materials and Methods: A total of 156 men with erectile dysfunction due to organic, nonorganic and mixed origin was randomized into 2 parallel treatment groups rece iving titrations of an individual optimum dose of alprostadil alpha-cy clodextrin or moxisylyte chlorhydrate. Erectile response was measured by the buckling test. A positive test was associated with axial erecti on rigidity that did not buckle/deform to 1.0 kg. load. The buckling t est was repeated every 10 minutes for up to 60 minutes. Results: A tot al of 56 patients (75%) in the alprostadil alpha-cyclodextrin group an d 32 patients (40%) in the moxisylyte chlorhydrate group responded wit h at least 1 positive buckling test during the office period. Investig ators assessed erections after alprostadil alpha-cyclodextrin to be ad equate for sexual intercourse in 61 patients (81%) compared to 37 pati ents (46%) after moxisylyte chlorhydrate. All efficacy parameters in o ffice reached statistical significance of p < 0.001 in favor of alpros tadil alpha-cyclodextrin. During self-injection therapy at home 58 pat ients (85%) reported at least 1 rigid erection after alprostadil alpha -cyclodextrin compared to 37 patients (61%) after moxisylyte chlorhydr ate. Patient and partner opinion of treatment achieved statistically s ignificantly better scores in the alprostadil alpha-cyclodextrin group compared to the moxisylyte chlorhydrate group. Conclusions: Alprostad il alpha-cyclodextrin is significantly more effective than moxisylyte chlorhydrate in producing full penile rigidity in office and at home. Injection related side effects occur with the same frequency but moxis ylyte results in more systemic side effects and alprostadil results in more painful and prolonged erections. Patients and partners are signi ficantly more satisfied with alprostadil alpha-cyclodextrin.