Trial Condition(s):

Erectile Dysfunction

BAY38-9456, 5/10/20mg, vs.placebo in Erectile Dysfunction

Bayer Identifier:

11382

ClinicalTrials.gov Identifier:

NCT00665054

EudraCT Number:

Not Available

Study Completed

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
160
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Dokuz Eylul Universitesi

Izmir, Turkey, 35340

Status
Completed
 
Locations

Cukurova Universitesi Tip Fakultesi Hastanesi

Adana, Turkey, 01330

Status
Completed
 
Locations

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, Turkey, 34098

Status
Completed
 
Locations

Marmara University Medical Faculty

Istanbul, Turkey, 34662

Status
Completed
 
Locations

19 Mayis Univ. Tip Fak.

Samsun, Turkey, 55139

Status
Completed
 
Locations

Akdeniz Univ. Medical Faculty

Antalya, Turkey, 07003

Status
Completed
 
Locations

Gazi Univ. Medical Faculty

Ankara, Turkey, 06500

Status
Completed
 
Locations

Hacettepe Univ. Medical Faculty

Ankara, Turkey, 06100

Status
Completed
 

Trial Design