Text Size

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
History of Changes
  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:

U.S. FDA Resources

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:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

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 May 16, 2013