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Vardenafil Treatment Of Erectile Dysfunction In Depressive And Non-Depressive Men

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ClinicalTrials.gov Identifier: NCT00470873
Recruitment Status : Completed
First Posted : May 8, 2007
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The primary aim of this open, uncontrolled, prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. The secondary aim of this study is to assess the influence of the treatment with Levitra on self-esteem (depressive symptomology) in men with ED.

Condition or disease Intervention/treatment
Erectile Dysfunction Drug: Levitra (Vardenafil, BAY38-9456)

Study Type : Observational
Actual Enrollment : 2471 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-Interventional, Post-Marketing Surveillance Phase IV Study to Obtain Data on Safety and Efficacy of Levitra® in Routine Treatment of Erectile Dysfunction in Depressive and Non-Depressive Men.
Study Start Date : January 2007
Actual Study Completion Date : February 2008


Group/Cohort Intervention/treatment
Group 1 Drug: Levitra (Vardenafil, BAY38-9456)
Primary care erectile dysfunction patients for whom physician decided to start the treatment with vardenafil




Primary Outcome Measures :
  1. Efficacy, safety, tolerance of the treatment with Vardenafil reported by the physician [ Time Frame: At the patients control visit (approx. 3 months from the initial) ]

Secondary Outcome Measures :
  1. Influence of vardenafil on depressive symptoms and self-esteem measured with CES-D and Rosenberg scale [ Time Frame: At the patients control visit (approx. 3 months from the initial) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care erectile dysfunction patients for whom physician decided to start the treatment with vardenafil
Criteria

Inclusion Criteria:

  • Age over 18
  • Erectile dysfunction untreated or ineffectively treated with other than vardenafil PDE5 inhibitors

Exclusion Criteria:

  • Treatment with nitrates
  • Allergy to vardenafil or other tablets ingredients
  • Treatment with CYP3A4 inhibitors (e.g. indinavir, ritonavir, ketoconazole, itraconazole, erythromycin)
  • Cardiovascular status excluding any sexual activity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470873


Locations
Poland
Many locations, Poland
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00470873     History of Changes
Obsolete Identifiers: NCT00459394
Other Study ID Numbers: 12842
LV0610PL
VALOR
First Posted: May 8, 2007    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents