BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: LOCF improved compared to baseline GAQ results at the end of the study
Secondary outcome: IIEF scoresOF, SD, IS scores in IIEF Questionnaire Scores of all individual questions on IIEF questionnaire Subject's diary response SSES-E scores Summary score from the responses to SSES-E Response scores and summary score from the responses to the SF-36
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Male.
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).
Locations and Contacts
Adana 01330, Turkey
Ankara 06100, Turkey
Ankara 06500, Turkey
Antalya 07003, Turkey
Istanbul 34098, Turkey
Istanbul 34662, Turkey
Izmir 35340, Turkey
Samsun 55139, Turkey
Additional Information
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Starting date: August 2004
Last updated: December 23, 2014
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