Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i
Status:
Unknown status
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
A prospective, randomized, 3-arm parallel trial on 45 males with ED that were never exposed
to PDE5i therapy (naïve patients) will be enrolled.In each group, every patient will receive
three treatment regimes (Viagra®50mg & Levitra®10mg, Viagra®100mg, Levitra®20mg), in
different sequences of administration in such a manner that eventually each patient will
receive all regimes in a double- blinded fasion.Safety will be evaluated at pre- screening by
measuring hourly vital signs (blood pressure, heart rate)for 4 consecutive hours after taking
half-dose combination. Any decrease in blood pressure of 20 mmhg below baseline will exclude
the subject from the study. Effcacy will be evaluated by questionnaires (IIEF, Quality of
erection questionnaire, grade of erection scale, Sear, QVS and Sexual Encounter Profiles for
each sexual event). Non-parametric statistical analysis of the collected data Comparing the 3
groups will be performed.