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 drug developed by Bayer AG for erectile dysfunction and urologic conditions. It is also known by the brand name Levitra and by the research code BAY38-9456. Vardenafil is a PDE5A inhibitor that has been studied in Phase 3 clinical development for erectile dysfunction, including cases secondary to spinal cord injury.
Vardenafil has been studied for erectile dysfunction, including erectile dysfunction solely secondary to spinal cord injury, as well as overactive bladder, detrusor overactivity, and benign prostatic hypertrophy. Its clinical development spans these urologic and endocrine-related indications, with the erectile dysfunction program reaching Phase 3.
Vardenafil targets PDE5A, also known as phosphodiesterase type 5. It acts as an inhibitor of this enzyme. By inhibiting PDE5A, vardenafil belongs to the PDE5 inhibitor drug class, a well-established mechanism in the treatment of erectile dysfunction.
Vardenafil is developed by Bayer AG, which trades under the ticker BAYRY. Bayer AG is the sponsor of the clinical trials evaluating vardenafil across erectile dysfunction and other urologic conditions.
Vardenafil has reached Phase 3 clinical development. Its Phase 3 trial evaluated the drug in patients with erectile dysfunction solely secondary to spinal cord injury. Additional Phase 2 trials have studied vardenafil in overactive bladder, detrusor overactivity, and benign prostatic hypertrophy.
Vardenafil has been studied in completed trials including NCT00654680, a Phase 3 trial in erectile dysfunction secondary to spinal cord injury with 418 patients, NCT00478881, a Phase 2 trial in overactive bladder and detrusor overactivity, and NCT00461123, a Phase 2 trial in benign prostatic hypertrophy.
Yes, vardenafil is the active ingredient marketed under the brand name Levitra. It is also known by the research code BAY38-9456 and as vardenafil HCl. These names refer to the same PDE5A inhibitor developed by Bayer AG.