BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction
This study has been completed.
Sponsor:
Bayer
Collaborator:
GlaxoSmithKline
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00665054
First received: April 18, 2008
Last updated: June 29, 2009
Last verified: June 2009
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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
| Condition | Intervention | Phase |
|---|---|---|
|
Erectile Dysfunction |
Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
MedlinePlus related topics:
Erectile Dysfunction
Drug Information available for:
Vardenafil
Vardenafil hydrochloride
Vardenafil dihydrochloride
Vardenafil hydrochloride trihydrate
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- IIEF scores [ Time Frame: visits 3, 4 and 5 ] [ Designated as safety issue: No ]
- OF, SD, IS scores in IIEF Questionnaire [ Time Frame: visits 2, 3, 4, 5 or at premature termination visit ] [ Designated as safety issue: No ]
- Scores of all individual questions on IIEF questionnaire [ Time Frame: visits 2, 3, 4, 5 or at premature termination visit ] [ Designated as safety issue: No ]
- Subject's diary response [ Time Frame: baseline and after randomization per visit period ] [ Designated as safety issue: No ]
- SSES-E scores [ Time Frame: visits 2 and 5 or premature termination visit ] [ Designated as safety issue: No ]
- Summary score from the responses to SSES-E [ Time Frame: visits 2 and 5 or premature termination visit ] [ Designated as safety issue: No ]
- Response scores and summary score from the responses to the SF-36 [ Time Frame: visits 2 and 5 or premature termination visit ] [ Designated as safety issue: No ]
| Enrollment: | 150 |
| Study Start Date: | August 2004 |
| Study Completion Date: | August 2005 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Levitra (Vardenafil, BAY38-9456)
5, 10, or 20 mg Vardenafil tablets orally prior to sexual activity
|
| Placebo Comparator: Arm 2 |
Drug: Placebo
Matching placebo tablets orally prior to sexual activity
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665054
Locations
| Turkey | |
| Adana, Turkey, 01330 | |
| Ankara, Turkey, 06100 | |
| Ankara, Turkey, 06500 | |
| Antalya, Turkey, 07003 | |
| Istanbul, Turkey, 34098 | |
| Istanbul, Turkey, 34662 | |
| Izmir, Turkey, 35340 | |
| Samsun, Turkey, 55139 | |
Sponsors and Collaborators
Bayer
GlaxoSmithKline
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG |
| ClinicalTrials.gov Identifier: | NCT00665054 History of Changes |
| Other Study ID Numbers: | 11382 |
| Study First Received: | April 18, 2008 |
| Last Updated: | June 29, 2009 |
| Health Authority: | Turkey: Ethics Committee Turkey: Ministry of Health |
Keywords provided by Bayer:
|
Vardenafil Erectile dysfunction SSES-E (sexual self-efficacy scale - erectile function) |
Additional relevant MeSH terms:
|
Erectile Dysfunction Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders Vardenafil Vasodilator Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013