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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00663130
Enrollment
759
Registered
2008-04-22
Start date
2004-04-30
Completion date
2004-07-31
Last updated
2013-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction, Vardenafil

Brief 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

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

Vardenafil 10mg, taken orally within 1 hour prior to sexual intercourse

DRUGTadalafil

Tadalafil 10mg, taken orally within 1 hour prior to sexual intercourse

Sponsors

GlaxoSmithKline
CollaboratorINDUSTRY
Bayer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Sexual Encounter Profile Question 3 (SEP-3)4 weeks

Secondary

MeasureTime frame
Sexual Encounter Profile Question 2 (SEP-2)4 weeks
International Index of Erectile Function4 weeks
Global Confidence Question (GCQ)4 weeks
Erection Quality Scale (EQS)4 weeks
General Safety4 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026