Clinical trial NCT01106118: Therapeutic Effectiveness of Vardenafil in Patients With Erectile Dysfunction and Metabolic Syndrome in Daily Clinical Practice
Official title: Therapeutic Effectiveness of Vardenafil in ED Patients With the Metabolic Syndrome in Daily Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-04-19
Enrollment: 2289
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of erectile dysfunction and metabolic syndrome who get vardenafil in routine treatment

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: After approx 12 weeks
Secondary outcomes:
measure: Patients with an increase of 5 points in the Erectile Dysfunction domain of the IIEF after approx. 12 weeks
timeFrame: After approx. 12 weeks
measure: Subjects with normal erectile function (IIEF-EF ³26) After approx. 12 weeks
timeFrame: After approx. 12 weeks
measure: Subjects with mild Erectile Dysfunction (IIEF-EF 22-25) After approx. 12 weeks
timeFrame: After approx. 12 weeks
measure: Optional by country, the effect of vardenafil on health-related quality of life (HRQoL) using the Aging Males Symptoms (AMS) Scale
timeFrame: After approx. 12 weeks
Other outcomes:
Locations:
city: Many Locations
country: Egypt
city: Many Locations
country: Israel
city: Many Locations
country: Kazakhstan
city: Many Locations
country: Korea, Republic of
city: Many Locations
country: Kyrgyzstan
city: Many Locations
country: Lebanon
city: Many Locations
country: Russian Federation
city: Many Locations
country: Saudi Arabia
city: Many Locations
country: Singapore
city: Many Locations
country: Ukraine
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.2016.03.027. Epub 2016 Apr 14.