Assessment of Duration of Erection With Vardenafil 10 mg
This study has been completed.
Sponsor:
Bayer
Collaborator:
GlaxoSmithKline
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00663728
First received: April 17, 2008
Last updated: June 29, 2009
Last verified: June 2009
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Purpose
This study assessed the effect of 10mg vardenafil, taken on demand in an 'at home' setting, as compared to placebo (dummy medication with no pharmacological activity), on the duration of erection from the moment when the patient perceived his erection to be hard enough for penetration until withdrawal from the partner's vagina leading to successful completion which may or may not have included ejaculation. The patient used the stopwatch for the above assessments. The efficacy of oral ED treatments is measured by questionnaires and patient diaries.
| Condition | Intervention | Phase |
|---|---|---|
|
Erectile Dysfunction |
Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Crossover Study to Evaluate the Duration of Erection Following Vardenafil (10mg) Administration for Four Weeks in a Fixed Dose Regimen Compared to Placebo in Males With ED |
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:
- Effect of vardenafil on the duration of erection [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Perception of erection to be hard enough for penetration [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 200 |
| Study Start Date: | September 2004 |
| Study Completion Date: | April 2005 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Levitra (Vardenafil, BAY38-9456)
10mg Vardenafil taken orally 1 hour prior to sexual intercourse
|
| Placebo Comparator: Arm 2 |
Drug: Placebo
Matching placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males with erectile dysfunction
- Stable heterosexual relationship
Exclusion Criteria:
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months nitrate use
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Affairs Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT00663728 History of Changes |
| Other Study ID Numbers: | 11575 |
| Study First Received: | April 17, 2008 |
| Last Updated: | June 29, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bayer:
|
Erectile Dysfunction Vardenafil |
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 19, 2013