Real Life Safety and Efficacy of Vardenafil

This study has been terminated.
(Slow recruitment)
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01215409
First received: September 28, 2010
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

In this uncontrolled, non-randomized, prospective, local post-marketed surveillance study, data are obtained on safety and efficacy of LEVITRA® in routine treatment of erectile dysfunction. The general objectives are to evaluate the product safety (primarily by recording adverse events), efficacy and patient acceptance.


Condition Intervention
Erectile Dysfunction
Drug: Vardenafil (Levitra, BAY38-9456)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Vardenafil in Routine Treatment of Erectile Dysfunction

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • General assessment of patients concerning efficacy and tolerability of vardenafil treatment [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to first intercourse after intake of vardenafil [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Percentage of successful second intercourse within 24 hours [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Percentage of participants who are willing to continue treatment [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 377
Study Start Date: February 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Vardenafil (Levitra, BAY38-9456)
5 mg or 10 mg or 20 mg of Vardenafil, orally when necessary for 2 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinics

Criteria

Inclusion Criteria:

  • Any adult patient (>/=18 years) with erectile dysfunction treated with LEVITRA®.
  • Patients must be able to give written informed consent for participation in the study after receiving detailed written and oral information prior to the study.

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the product information (Package Insert).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01215409

Locations
Taiwan
Many Locations, Taiwan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01215409     History of Changes
Other Study ID Numbers: 14328, LV0611TW
Study First Received: September 28, 2010
Last Updated: May 14, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Bayer:
Levitra
Erectile dysfunction
Taiwan

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 22, 2014