Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)

Erectile Dysfunction Clinical Trial

Official title:

A Randomised, Double-blind, Double-dummy, Parallel-group, Active-controlled Study Evaluating the Efficacy of Vardenafil Versus Tadalafil When Intercourse is Attempted Within 45 Minutes of Administration in Subjects With Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663130
• Other study ID #: 11333
• Status: Completed
• Phase: Phase 4
• First received: April 17, 2008
• Last updated: October 9, 2013
• Start date: April 2004
• Est. completion date: July 2004

Study information

• Verified date: October 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe ED

Recruitment information / eligibility

• Status: Completed
• Enrollment: 759
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 64 years

• Heterosexual males

• Erectile dysfunction for more than 6 months

Exclusion Criteria:

• Penile anatomical abnormalities

• Spinal cord injury

• History of surgical prostatectomy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Levitra (Vardenafil, BAY38-9456)
Vardenafil 10mg, taken orally within 1 hour prior to sexual intercourse
• Tadalafil
Tadalafil 10mg, taken orally within 1 hour prior to sexual intercourse

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Encounter Profile Question 3 (SEP-3)		4 weeks	No
Secondary	Sexual Encounter Profile Question 2 (SEP-2)		4 weeks	No
Secondary	International Index of Erectile Function		4 weeks	No
Secondary	Global Confidence Question (GCQ)		4 weeks	No
Secondary	Erection Quality Scale (EQS)		4 weeks	No
Secondary	General Safety		4 weeks	Yes

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