Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vardenafil ODT · 2 trials · 1 indication
The primary variable was the treatment group difference from baseline to Week 12 or LOCF of the least square mean difference in the IIEF-EF domain score (Range: 1-30 ordinal. Directionality: severity of erectile dysfunction: \<=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; \>25 'no ED'.)
SEP (Sexual Encounter Profile) 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.
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.
| Arm | Type | Description |
|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | EXPERIMENTAL | Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. |
| Arm1 | EXPERIMENTAL | - |
| Arm2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | DRUG | Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10 mg orodispersible tablet (ODT) |
| Placebo | DRUG | Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet |
| Vardenafil ODT, (Staxyn, BAY38-9456) | DRUG | Single dose of 10 mg of vardenafil ODT, taken without water |
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...
Vardenafil ODT is used for erectile dysfunction in men. It is an orally disintegrating tablet formulation of vardenafil, a small molecule being developed by Bayer AG. The drug is currently in Phase 3 clinical development and remains investigational, not yet approved by regulatory authorities.
Vardenafil ODT works by inhibiting the enzyme phosphodiesterase type 5, which increases blood flow to the penis, facilitating an erection in response to sexual stimulation. This mechanism is typical of PDE5 inhibitors used to treat erectile dysfunction.
Vardenafil ODT is developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. The drug is in Phase 3 clinical trials for erectile dysfunction and is not yet approved for commercial use.
Vardenafil ODT is in Phase 3 clinical development for erectile dysfunction. It has completed two clinical trials, including a Phase 3 efficacy study and a Phase 1 drug interaction study, but it is still investigational and not FDA approved.
Vardenafil ODT has completed two clinical trials: NCT00655629, a Phase 3 placebo-controlled study in 339 men with erectile dysfunction, and NCT01348880, a Phase 1 interaction study with nifedipine in 42 men. Both trials are completed, and no active trials are ongoing.