Vardenafil Treatment of Erectile Dysfunction in Depressive and Non-Depressive Men

Condition(s) targeted: Impotence

Status: Recruiting

Sponsored by: Bayer Schering Pharma Sp. z o.o., Polska

Official(s) and/or principal investigator(s):
Barbara Darewicz, Professor, Study Chair, Affiliation: Medical University of Bialystok, Klinika Urologii, ul. M. Skłodowskiej-Curie 24A, 15-276 Bialystok, Poland

Overall contact:
Michal Wronka, Dr, Phone: 0048 022 572 38 81, Email: michal.wronka.mw@bayer-ag.de

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.

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 design: Observational, Screening, Cross-Sectional, Defined Population, Prospective Study

Detailed description: Erectile dysfunction (ED), defined as the persistent inability to achieve or maintain an erection sufficient enough for satisfactory sexual performance, is a highly prevalent disorder in men and can have negative effects on mood state, interpersonal relationship and quality of life. The Population-based Massachusetts Male Aging Study found that 52% of men aged 40-70 experienced at least some degree of self-reported ED, and it is estimated that ED will affect 322 million men worldwide by the year 2025 [Aytac IA et al., Br J Urol Int. 1999, Johannes CB et al., J Urol 2000]. Development of ED is strongly related to the presence of organic and psychological risk factors. The psychological conditions associated with erectile dysfunction include depression, anxiety and anger. Clinical studies to evaluate ED therapies typically have used self-report measures that focus on specific domains of sexual function. Less attention has been paid to the broader psychological and behavioral aspects of ED. Several disease specific and non-specific measures that assess psychosocial domains have been developed for use in studies of ED. In few placebo-controlled clinical trials which used this measures, it has been proved that vardenafil can positively influe self-esteem (depressive symptomology) in men with ED [Hatzichristou D et al., J Sex Med 2005, Martin-Morales A et al., J Sex Med 2006]. “VALOR” is the first non-interventional study designed to asses the influence of vardenafil treatment on self-esteem (depressive symptomology) in the broad population of men with ED in Poland.

Minimum age: 18 Years. Gender(s): Male.

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 (eg, indinavir, ritonavir, ketoconazole, itraconazole, erythromycin)

- cardiovascular status excluding any sexual activity

Michal Wronka, Dr, Phone: 0048 022 572 38 81, Email: michal.wronka.mw@bayer-ag.de

Przychodnia Lekarska "Multi-Med", Czestochowa 42-200, Poland; Recruiting
Petelewicz Stanislaw, Dr, Principal Investigator

Related publications:

Hatzichristou D, Cuzin B, Martin-Morales A, Buvat J, Porst H, Laferriere N, Bandel TJ, Montorsi F; Vardenafil Study Group. Vardenafil improves satisfaction rates, depressive symptomatology, and self-confidence in a broad population of men with erectile dysfunction. J Sex Med. 2005 Jan;2(1):109-16.

Martin-Morales A, Meijide Rico F, Garcia Gonzalez JI, Regadera Anechina L, Manero Font M. [Psychological impact of erectile dysfunction on self-esteem and self-confidence] Actas Urol Esp. 2005 May;29(5):493-8. Spanish.

Starting date: January 2007
Ending date: July 2007
Last updated: April 10, 2007