Evaluation of the Safety and Efficacy of Vardenafil in Subjects With Erectile Dysfunction
This study has been completed.
Sponsor:
Bayer
Collaborator:
GlaxoSmithKline
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00681772
First received: April 18, 2008
Last updated: June 16, 2009
Last verified: June 2009
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Purpose
Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology.
| Condition | Intervention | Phase |
|---|---|---|
|
Erectile Dysfunction |
Drug: Levitra (Vardenafil, BAY38-9456) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-Label, Multi-Centre, Study to Investigate the Safety, Tolerability and Efficacy of Flexible Doses of Vardenafil Given on Demand in Males 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:
- International Index of Erectile Function - Erectile Function Domain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Sexual Encounter Profile Question 2 and 3 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Global Assessment Question [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Other diary based variables [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 333 |
| Study Start Date: | March 2003 |
| Study Completion Date: | November 2003 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Levitra (Vardenafil, BAY38-9456)
5mg, 10mg or 20mg taken 1 hours before sexual intercourse
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men >/= 18 years of age, with
- ED 6 months or longer
- Stable sexual relationship for > 6 month.
Exclusion Criteria:
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
- Nitrate therapy
- Other exclusion criteria apply according to the Summary of Product Characteristics
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Affairs Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT00681772 History of Changes |
| Other Study ID Numbers: | 100541 |
| Study First Received: | April 18, 2008 |
| Last Updated: | June 16, 2009 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: National Health and Medical Research Council |
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 June 18, 2013