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Real Life Safety and Efficacy of Vardenafil

This study has been terminated.
(Slow recruitment)
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01215409
First received: September 28, 2010
Last updated: May 16, 2014
Last verified: May 2014
  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: 372
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Bayer
ClinicalTrials.gov Identifier: NCT01215409     History of Changes
Other Study ID Numbers: 14328, LV0611TW
Study First Received: September 28, 2010
Last Updated: May 16, 2014
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Bayer:
Levitra
Erectile dysfunction
Taiwan

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

ClinicalTrials.gov processed this record on November 27, 2014