CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 339 enrolled
Drug / intervention
Vardenafil ODT (STAXYN, BAY38-9456) +1 moredrug
Likely dose
Vardenafil ODT (STAXYN, BAY38-9456) 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00655629
NCT00655629Phase 3Completed
CompareCT.gov

Pivotal Phase III Trial to Investigate the Efficacy and Safety of an Orodispersible Tablet Vardenafil Versus Placebo in the Treatment of Men With Erectile Dysfunction (ED) - a Fixed-dose, Double-blind, Randomized Multi-center Trial

Bayer·interventional·Posted Apr 10, 2008·Updated Aug 1, 2014

In Brief

A Phase 3 clinical trial evaluating Vardenafil ODT (STAXYN, BAY38-9456) and Placebo for Erectile Dysfunction. Completed, enrolled 339 participants across 40 sites in 4 countries.

Detailed Summary

This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErectile Dysfunction
CountriesAustralia, Canada, Mexico, United States
CollaboratorsGlaxoSmithKline, Schering-Plough

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 10, 2008
Enrollment StartApr 1, 2008
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.2 years ago

Interventions

Vardenafil ODT (STAXYN, BAY38-9456)drug

Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10 mg orodispersible tablet (ODT)

Placebodrug

Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet