Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vardenafil · 3 trials · 4 indications
Bladder volume was measure by means of urodynamic assessments (cystometry) for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF).
Change from baseline in the number of daily micturitions (bladder voidings), as reported in the participant diaries for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF).
Baseline (pre-surgery Day -1) adjusted least squares (LS)-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in peak urinary flow.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | PLACEBO_COMPARATOR | - |
| Vardenafil HCl (Levitra, BAY38-9456) | EXPERIMENTAL | vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks |
| Placebo | PLACEBO_COMPARATOR | vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks |
| Vardenafil (Levitra, BAY38-9456) | EXPERIMENTAL | One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced. |
| Name | Type | Description |
|---|---|---|
| Vardenafil (Levitra, BAY38-9456) | DRUG | 5mg, 10mg or 20mg taken 1 hour prior to sexual intercourse |
| Placebo | DRUG | Matching placebo |
| Vardenafil HCl (Levitra, BAY38-9456) | DRUG | vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks |
Inclusion Criteria: * Males ≥18 years with erectile dysfunction (ED) solely as a result of traumatic spinal cord injury (SCI) for ≥6 months with demonstrated 50% failure in intercourse attempts during the 4-week run-in period. * Stable heterosexual relationship for at least 1 month. Exclusion Crit...
Vardenafil is a small molecule being studied for overactive bladder, erectile dysfunction, and benign prostatic hypertrophy. It is developed by Bayer AG and is in Phase 3 clinical development for erectile dysfunction. The drug is investigational and not yet approved for these uses.
Vardenafil is a phosphodiesterase type 5 (PDE5) inhibitor, which works by increasing blood flow to specific areas of the body. It is being studied for its effects on bladder function and erectile dysfunction. The drug's mechanism involves relaxing smooth muscles and enhancing vasodilation.
Vardenafil is developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the drug's safety and efficacy for various urological and sexual health conditions.
Vardenafil is in Phase 3 clinical development for erectile dysfunction. It has completed Phase 2 trials for overactive bladder and benign prostatic hypertrophy. The drug is investigational and has not been approved by regulatory authorities for these indications.
Vardenafil has completed three clinical trials: NCT00461123 for benign prostatic hypertrophy, NCT00478881 for overactive bladder, and NCT00654680 for erectile dysfunction. The Phase 3 trial NCT00654680 enrolled 418 patients to evaluate efficacy and safety in erectile dysfunction secondary to spinal cord injury.
Vardenafil is the active ingredient in Levitra, a medication used for erectile dysfunction. However, the clinical trials described here are for investigational uses beyond the approved indication. Vardenafil is being studied for overactive bladder and benign prostatic hypertrophy, which are not approved uses.