Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Tadalafil (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
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
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Sexual Encounter Profile Question 3 (SEP-3)
Secondary outcome: Sexual Encounter Profile Question 2 (SEP-2)International Index of Erectile Function Global Confidence Question (GCQ) Erection Quality Scale (EQS) General Safety
Detailed description:
Surveys of sexual habits and behaviour have provided information on the 'window of
opportunity' during which an ED medication should be effective. According to these surveys,
the average time from thinking about having sex to doing so is less than 1 hour. Most men are
unable to predict when they might have sex more than 30 minutes in advance. The aim of the
present study was to compare the efficacy and tolerability of the licensed starting doses of
vardenafil (10 mg) and tadalafil (10 mg) in patients with erectile issues (erectile
dysfunction) who attempted sexual intercourse within 45 minutes of drug administration (i. e.
during the early window of opportunity).
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Additional Information
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Starting date: April 2004
Ending date: July 2004
Last updated: April 17, 2008
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