Real Life Safety and Efficacy of Vardenafil

Erectile Dysfunction Clinical Trial

Official title:

Vardenafil in Routine Treatment of Erectile Dysfunction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01215409
• Other study ID #: 14328
• Secondary ID: LV0611TW
• Status: Terminated
• Phase: N/A
• First received: September 28, 2010
• Last updated: May 16, 2014
• Start date: February 2008
• Est. completion date: November 2008

Study information

• Verified date: May 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 372
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Vardenafil (Levitra, BAY38-9456)
5 mg or 10 mg or 20 mg of Vardenafil, orally when necessary for 2 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General assessment of patients concerning efficacy and tolerability of vardenafil treatment		2 months	Yes
Secondary	Time to first intercourse after intake of vardenafil		2 months	No
Secondary	Percentage of successful second intercourse within 24 hours		2 months	No
Secondary	Percentage of participants who are willing to continue treatment		2 months	No
Secondary	Number of participants with adverse events		2 months	Yes

External Links

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