NCT01106118

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
10 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

2.9 years

First QC Date

April 16, 2010

Last Update Submit

October 14, 2016

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Patients with an increase of 5 points in the Erectile Dysfunction domain of the IIEF after approx. 12 weeks

    After approx. 12 weeks

  • Subjects with normal erectile function (IIEF-EF ³26) After approx. 12 weeks

    After approx. 12 weeks

  • Subjects with mild Erectile Dysfunction (IIEF-EF 22-25) After approx. 12 weeks

    After approx. 12 weeks

  • 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

Study Arms (1)

Group 1

Drug: Vardenafil (Levitra, BAY38-9456)

Interventions

Vardenafil (Levitra, BAY38-9456)DRUG

Patients with diagnosis of erectile dysfunction and metabolic syndrome who get vardenafil in routine treatment as prescribed by physician

Group 1

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosis of erectile dysfunction and metabolic syndrome who get vardenafil in routine treatment

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Many Locations, Egypt

Location

Unknown Facility

Many Locations, Israel

Location

Unknown Facility

Many Locations, Kazakhstan

Location

Unknown Facility

Many Locations, Kyrgyzstan

Location

Unknown Facility

Many Locations, Lebanon

Location

Unknown Facility

Many Locations, Russia

Location

Unknown Facility

Many Locations, Saudi Arabia

Location

Unknown Facility

Many Locations, Singapore

Location

Unknown Facility

Many Locations, South Korea

Location

Unknown Facility

Many Locations, Ukraine

Location

Related 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.2016.03.027. Epub 2016 Apr 14.

    PMID: 27151768RESULT

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2010

First Posted

April 19, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2012

Study Completion

August 1, 2013

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

RU(1)EG(1)SG(1)KR(1)KY(1)SA(1)IL(1)UA(1)LE(1)KA(1)