Purpose of the study is:- To assess the efficacy and tolerability of vardenafil in male subjects suffering from erectile dysfunction as compared to placebo- To assess the influence of vardenafil on the self-esteem and self-confidence of subjects suffering from erectile dysfunction following treatment with vardenafil as compared to placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
5, 10, or 20 mg Vardenafil tablets orally prior to sexual activity
Matching placebo tablets orally prior to sexual activity
Unnamed facility
Adana, Turkey (Türkiye)
Unnamed facility
Ankara, Turkey (Türkiye)
Unnamed facility
Ankara, Turkey (Türkiye)
Unnamed facility
Antalya, Turkey (Türkiye)
LOCF improved compared to baseline GAQ results at the end of the study
Time frame: baseline versus visit 2 visit 5 or premature termination visit
IIEF scores
Time frame: visits 3, 4 and 5
OF, SD, IS scores in IIEF Questionnaire
Time frame: visits 2, 3, 4, 5 or at premature termination visit
Scores of all individual questions on IIEF questionnaire
Time frame: visits 2, 3, 4, 5 or at premature termination visit
Subject's diary response
Time frame: baseline and after randomization per visit period
SSES-E scores
Time frame: visits 2 and 5 or premature termination visit
Summary score from the responses to SSES-E
Time frame: visits 2 and 5 or premature termination visit
Response scores and summary score from the responses to the SF-36
Time frame: visits 2 and 5 or premature termination visit
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Unnamed facility
Istanbul, Turkey (Türkiye)
Unnamed facility
Istanbul, Turkey (Türkiye)
Unnamed facility
Izmir, Turkey (Türkiye)
Unnamed facility
Samsun, Turkey (Türkiye)