Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vardenafil ODT · 1 trial · 1 indication
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').
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.
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. |
| Name | Type | Description |
|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | DRUG | Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT) |
| Placebo | DRUG | Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet |
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...
Vardenafil ODT is used for the treatment of erectile dysfunction in men. It is an orally disintegrating tablet formulation of vardenafil, a small molecule developed by GSK plc. The drug is currently in Phase 3 clinical development and is being evaluated for its efficacy and safety in this indication.
Vardenafil ODT targets the enzyme phosphodiesterase type 5 (PDE5). By inhibiting PDE5, it helps to increase blood flow to the penis, facilitating an erection in response to sexual stimulation. This mechanism is the basis for its use in treating erectile dysfunction.
Vardenafil ODT is being developed by GSK plc, a global pharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of erectile dysfunction.
Vardenafil ODT is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will be used to support a potential regulatory submission.
Vardenafil ODT has one completed Phase 3 clinical trial, identified as NCT00631969. This randomized, double-blind, placebo-controlled study enrolled 362 male participants with erectile dysfunction across multiple countries, including Belgium, France, Germany, Netherlands, South Africa, and Spain.
Vardenafil ODT is an orally disintegrating tablet formulation of vardenafil, the active ingredient. While the active drug is the same, the ODT formulation is designed to dissolve quickly in the mouth without water, offering a different route of administration compared to standard vardenafil tablets.