Real Life Safety and Efficacy of Vardenafil

• Sponsor: Bayer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01215409
• Collaborator: (none)
• Enrollment: 372
• Location: 1
• Duration (Months): 9
• Patients Per Site Per Month: 41.3

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Vardenafil (Levitra, BAY38-9456)

Study Design

• Study Type: Observational
• Actual Enrollment: 372 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Vardenafil in Routine Treatment of Erectile Dysfunction
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Group 1	Drug: Vardenafil (Levitra, BAY38-9456); 5 mg or 10 mg or 20 mg of Vardenafil, orally when necessary for 2 months

Outcome Measures

Primary Outcome Measures

1. General assessment of patients concerning efficacy and tolerability of vardenafil treatment [2 months]

Secondary Outcome Measures

1. Time to first intercourse after intake of vardenafil [2 months]

2. Percentage of successful second intercourse within 24 hours [2 months]

3. Percentage of participants who are willing to continue treatment [2 months]

4. Number of participants with adverse events [2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		Taiwan

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01215409
• Other Study ID Numbers: 14328; LV0611TW
• First Posted: Oct 6, 2010
• Last Update Posted: May 19, 2014
• Last Verified: May 1, 2014

• Keywords provided by Bayer: Levitra; Erectile dysfunction; Taiwan
• Additional relevant MeSH terms: Erectile Dysfunction; Vardenafil Dihydrochloride

Study Results

No Results Posted as of May 19, 2014