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Levitra · 19 trials · 8 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 3 | PLACEBO_COMPARATOR | - |
| Arm 4 | PLACEBO_COMPARATOR | - |
| Arm 5 | PLACEBO_COMPARATOR | - |
| Arm 6 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Levitra (Vardenafil, BAY38-9456) | DRUG | 9 months DAILY dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication |
| Placebo | DRUG | 9 months placebo (double blind)2 months single-blind placebo wash-out period (subject only is blinded)2 months open-label PRN treatment with active medication |
| Tadalafil | DRUG | 10 mg taken approximately 24 hours prior to sexual intercourse |
Inclusion Criteria: At Screening * Males 18-64 years of age * Scheduled to undergo bilateral nerve-sparing radical retropubic BNSRRP, as selected according to the investigator's usual clinical practice * Surgery scheduled within about 1 month of screening (Visit 1) * Expressed an interest in resum...
Levitra is used to treat erectile dysfunction. It has also been studied in benign prostatic hyperplasia and tinnitus. The clinical program covers these urology indications, with 17 completed trials and a total enrollment of 7,861 participants across randomized, double-blind, placebo-controlled studies.
Levitra is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer conducted the clinical development program for the drug, including the pivotal Phase 3 trials in erectile dysfunction and the Phase 2 study comparing once-daily and as-needed dosing.
Levitra is in Phase 2 development based on the current pipeline listing, and it is investigational rather than approved in this program. All 17 listed trials are completed, with none currently active, and the studies span Phase 2 and Phase 3 across erectile dysfunction and related conditions.
Levitra has been studied in completed trials including NCT00786253, a Phase 2 study of once-daily versus as-needed vardenafil in erectile dysfunction, and Phase 3 trials NCT00682019, NCT00678704 in diabetes patients, and NCT00668109 in patients with diabetes, hypertension or hyperlipidemia. All 17 trials are completed with no active studies.
Yes, Levitra is the brand name for vardenafil, and it was also known during development as BAY38-9456. Vardenafil is a small molecule developed by Bayer AG, and the alternative names refer to the same drug studied across the erectile dysfunction, benign prostatic hyperplasia and tinnitus programs.
Levitra trials enrolled a total of 7,861 participants across 17 completed studies. The program used randomized, double-blind, placebo-controlled designs. Individual trials ranged from 236 participants in the Phase 2 once-daily versus as-needed study to 790 participants in the Phase 3 pivotal trial for diabetes patients.