Trial Condition(s):
Erectile Dysfunction
BAY38-9456, 5/10/20mg, vs.placebo in Erectile Dysfunction
Bayer Identifier:
11382
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
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).
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Dokuz Eylul Universitesi Izmir, Turkey, 35340 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cukurova Universitesi Tip Fakultesi Hastanesi Adana, Turkey, 01330 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Istanbul Universitesi Cerrahpasa Tip Fakultesi Istanbul, Turkey, 34098 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Marmara University Medical Faculty Istanbul, Turkey, 34662 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 19 Mayis Univ. Tip Fak. Samsun, Turkey, 55139 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akdeniz Univ. Medical Faculty Antalya, Turkey, 07003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gazi Univ. Medical Faculty Ankara, Turkey, 06500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hacettepe Univ. Medical Faculty Ankara, Turkey, 06100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- LOCF improved compared to baseline GAQ results at the end of the studyTimeframe: baseline versus visit 2 visit 5 or premature termination visit
Secondary Outcome
- IIEF scoresTimeframe: visits 3, 4 and 5
- OF, SD, IS scores in IIEF QuestionnaireTimeframe: visits 2, 3, 4, 5 or at premature termination visit
- Scores of all individual questions on IIEF questionnaireTimeframe: visits 2, 3, 4, 5 or at premature termination visit
- Subject's diary responseTimeframe: baseline and after randomization per visit period
- SSES-E scoresTimeframe: visits 2 and 5 or premature termination visit
- Summary score from the responses to SSES-ETimeframe: visits 2 and 5 or premature termination visit
- Response scores and summary score from the responses to the SF-36Timeframe: visits 2 and 5 or premature termination visit
Additional Information
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