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Time to Onset of Action of Vardenafil in Males With Erectile Dysfunction
NCT00665496Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2003
- Countries
- 11
- Sponsor
- Bayer
- Modality
- Small Molecules
- Drugs
- vardenafil
- Conditions
- erectile dysfunction (ED)
01
Overview
Phase 3, randomised, double-blind trial in erectile dysfunction (ED) comparing Vardenafil with Placebo (2 arms). Primary endpoint: Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration leading to completion of successful intercourse as measured by Sexual Encounter Profile… Started Jun 2003; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Vardenafil
Vardenafil 10 mg and 20 mg orally once a day as needed
Placebo
Matching Placebo
03
Who it enrols
Adult males with erectile dysfunction for more than 6 months in a heterosexual relationship, excluding those with primary hypoactive sexual desire or recent cardiovascular events.
04
Endpoints
Primary
Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration leading to completion of successful intercourse as measured by Sexual Encounter Profile…
Secondary
Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration as measured by Sexual Encounter Profile Question 2 (SEP 2)
The erectile function (EF) domain score of the International Index of Erectile Function (IIEF)
Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration
Safety and tolerability
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