Recent Updates
Recently added Catalysts

Vardenafil ODT

Phase 3

Erectile Dysfunction | Small molecule | Other |GSK plc|Last Updated: Dec 30, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment362
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00631969Vardenafil ODT Versus Placebo in Males With Erectile DysfunctionPHASE3 COMPLETED 362 — — Apr 1, 2008Jan 1, 2009Dec 30, 201447 Belgium, France +4
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF
from baseline up to 12 weeks

The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: \<=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; \>25 'no ED').

Change in Percentage From Baseline in Success of Penetration at 12 Weeks
from baseline up to 12 weeks of treatment

Sexual encounter profile (SEP) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.

Change From Baseline in Success of Erection Maintenance at 12 Weeks
from baseline up to 12 weeks of treatment

SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.

Secondary Endpoints
Percentage of Subjects Achieving "Back to Normal" Erectile Function
up to 12 weeks of treatment
Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
from baseline up to 12 weeks of treatment
Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
from baseline up to 12 weeks of treatment
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Vardenafil ODT (STAXYN, BAY38-9456)EXPERIMENTALVardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
PlaceboPLACEBO_COMPARATORMatching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Interventions
NameTypeDescription
Vardenafil ODT (STAXYN, BAY38-9456)DRUGSubjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT)
PlaceboDRUGSubjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites47

Inclusion Criteria: * Males 18 years-of-age or older * Stable, heterosexual relationship for at least 6 months * A history of erectile dysfunction (ED) for at least 6 months Exclusion Criteria: * Any underlying cardiovascular condition, including unstable angina pectoris * History of myocardial i...

Countries:BelgiumFranceGermanyNetherlandsSouth AfricaSpain
Unlock Eligibility Criteria