Therapeutic Effectiveness of Vardenafil in Patients With Erectile Dysfunction and Metabolic Syndrome in Daily Clinical Practice

Erectile Dysfunction Clinical Trial

— REVITALISE  

Official title:

Therapeutic Effectiveness of Vardenafil in ED Patients With the Metabolic Syndrome in Daily Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106118
• Other study ID #: 14872
• Secondary ID: LV0901
• Status: Completed
• Phase: N/A
• First received: April 16, 2010
• Last updated: October 14, 2016
• Start date: January 2010
• Est. completion date: August 2013

Study information

• Verified date: October 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionKazakhstan: National Center for Expertise of medicinal drugs, medical equipment and medical devicesKorea: Food and Drug AdministrationLebanon: Institutional Review BoardSingapore: Domain Specific Review BoardsSingapore: Health Sciences AuthorityUkraine: State Pharmacological Center - Ministry of HealthRussia: Ethics CommitteeKyrgyzstan: National Center for Expertise of medicinal drugs, medical equipment and medical devices
• Study type: Observational

Clinical Trial Summary

The primary goal of this international non-interventional study is to investigate the therapeutic effectiveness of vardenafil (film-coated tablet) in Erectile Dysfunction patients with the Metabolic Syndrome in daily clinical practice. It will include a large number of patients with various underlying conditions with different cultural and demographic backgrounds from different geographic areas.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2289
• Est. completion date: August 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Erectile Dysfunction (ED) patient who has newly been prescribed vardenafil (Levitra film-coated tablet) in accordance with the terms of the local marketing authorization.

• Diagnosis of erectile dysfunction at the discretion of the physician, based on the patients ED history.

• No use of any Phosphodiesterase Type 5 (PDE5) inhibitor within 1 month of study entry.

• Documented Metabolic Syndrome (MetS), preferably according to the definition of the International Diabetes Foundation.

Exclusion Criteria:

• Do not follow the contraindications and warnings of the Summary of Product Characteristics.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Erectile Dysfunction
• Metabolic Syndrome X

Intervention

Drug:
• Vardenafil (Levitra, BAY38-9456)
Patients with diagnosis of erectile dysfunction and metabolic syndrome who get vardenafil in routine treatment as prescribed by physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Egypt,  Israel,  Kazakhstan,  Korea, Republic of,  Kyrgyzstan,  Lebanon,  Russian Federation,  Saudi Arabia,  Singapore,  Ukraine, 

References & Publications (1)

Shabsigh R, Mattern A; REVITALISE Study Group. REVITALISE: A Large Observational Study Assessing the Safety and Effectiveness of Vardenafil in Men With Erectile Dysfunction and Metabolic Syndrome. Sex Med. 2016 Sep;4(3):e135-44. doi: 10.1016/j.esxm.2016.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients with a clinically relevant, intra-individual improvement in erectile function defined as an increase of 4 points in the erectile function domain of the International Index of Erectile Function (IIEF)		After approx 12 weeks	No
Secondary	Patients with an increase of 5 points in the Erectile Dysfunction domain of the IIEF after approx. 12 weeks		After approx. 12 weeks	No
Secondary	Subjects with normal erectile function (IIEF-EF ³26) After approx. 12 weeks		After approx. 12 weeks	No
Secondary	Subjects with mild Erectile Dysfunction (IIEF-EF 22-25) After approx. 12 weeks		After approx. 12 weeks	No
Secondary	Optional by country, the effect of vardenafil on health-related quality of life (HRQoL) using the Aging Males Symptoms (AMS) Scale		After approx. 12 weeks	No

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