Clinical trial NCT00665054: BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction
Official title: Multi-centre, Randomized, Double-blind, Parallel, Placebo-controlled Clinical Study to Assess the Efficacy and Tolerability of Vardenafil and Its Influence on Self-esteem and Self Confidence in Subjects With Erectile Dysfunction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Vardenafil
Erectile dysfunction
SSES-E (sexual self-efficacy scale - erectile function)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-04-23
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Men with heterosexual relationships aged 18 - 64 years suffering from ED for more than 6 months according to the NIH Consensus Statement (i.e. inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
* At least 4 attempts at sexual intercourse (according to the question in the subject diary) on 4 separate days during the 4-week untreated baseline period. At least 50% of attempts during this period had to be unsuccessful according to the subject diary.

Exclusion Criteria:

* Presence of penile anatomical abnormalities (eg penile fibrosis or Peyronie's disease) that in the investigator's opinion would significantly impair sexual performance.
* Primary hypoactive sexual desire.-Spinal cord injury-History of surgical prostatectomy (transurethral interventions not excluded).
* Unstable angina pectoris.
* History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.
* Uncontrolled atrial fibrillation/flutter at screening visit (ventricular response rate \>100 BPM).

Primary outcomes:
measure: LOCF improved compared to baseline GAQ results at the end of the study
timeFrame: baseline versus visit 2 visit 5 or premature termination visit
Secondary outcomes:
measure: IIEF scores
timeFrame: visits 3, 4 and 5
measure: OF, SD, IS scores in IIEF Questionnaire
timeFrame: visits 2, 3, 4, 5 or at premature termination visit
measure: Scores of all individual questions on IIEF questionnaire
timeFrame: visits 2, 3, 4, 5 or at premature termination visit
measure: Subject's diary response
timeFrame: baseline and after randomization per visit period
measure: SSES-E scores
timeFrame: visits 2 and 5 or premature termination visit
measure: Summary score from the responses to SSES-E
timeFrame: visits 2 and 5 or premature termination visit
measure: Response scores and summary score from the responses to the SF-36
timeFrame: visits 2 and 5 or premature termination visit
Other outcomes:
Locations:
city: Adana
country: Turkey
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Antalya
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Samsun
country: Turkey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: