Efficacy of Intracavernosal as add-on Therapy to Sildenafil 100 mg on Demand Compared to Sildenafil 100 mg on Demand for the Treatment of Erectile Dysfunction (ED) Not Sufficiently Responsive to Standard Therapy With Phosphodiesterase Type 5 Inhibitors (MENOX)
The primary objective of this study is to investigate the efficacy of intracavernosal
(Xeomin®) (100U) as add-on therapy to sildenafil 100 mg on demand in men with ED and
insufficient response to standard therapy with 100 mg sildenafil on demand during the 4-week
open-label run-in phase.
The secondary objectives are to further describe the efficacy and safety of (Xeomin®) 100U IC
as add-on therapy to sildenafil 100 mg on demand:
to further assess efficacy using.
i) a log diary five-item questionnaire completed after each sexual attempt (Sexual
ii) a self-reporting measure that scores erection hardness on a 4 point scale
completed after each sexual attempt;
iii) The Global Assessment Question.
to assess effect persistence at month 6 and month 9.
to assess safety of (Xeomin®) 100U IC in combination with sildenafil 100 mg on demand.
This randomized, double-blind, placebo-controlled study will be conducted in 9 centers, study
participants will be adult men with ED and insufficient response to standard therapy with 100
mg sildenafil on demand during the 4-week open label run-in-phase, follow-up in the study
will be 10±2 months.
This is a standard procedure to use placebo as control in studies assessing the efficacy of
pharmacological treatment of ED. Furthermore the placebo group provides a benchmark for an
objective analysis of safety and tolerability findings. The open-label run-in phase assures
that only subjects who are true non-responders i.e. with insufficient response to standard
therapy with 100 mg sildenafil prn during the 4-week open-label run-in phase are randomized
and participate in the double-blind treatment phase.
Participants distributed between groups at a ratio of 1:1.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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