Friday, August 29, 2014 11:44:46 AM
After application of Vitaros the onset of erection is within 5 to 30 minutes. Alprostadil has a short half-life in man and improvement of erections may last from 1 to 2 hours after dosing.
Efficacy: Two Pivotal Phase 3 studies evaluated the efficacy of Vitaros in patients with Erectile Dysfunction. Relative to placebo, a statistically significant overall improvement was observed in the 100, 200 and 300 mcg alprostadil treatment groups in each of the primary efficacy endpoints; i.e., the erectile function (EF) domain of the IIEF (International Index of Erectile Function) score and increased success in vaginal penetration and ejaculation. Additionally, there were also overall improvements and statistical significance of the treatment groups compared to placebo in several of the secondary efficacy variables, including the other IIEF domain scores (orgasmic function, intercourse satisfaction, and overall satisfaction), Patient Self-Assessment of Erection (PSAE), and Global Assessment Questionnaire (GAQ).
Subpopulation Efficacy: Similar improvements to those of all patients were generally observed within the subpopulations (diabetic, cardiac, prostatectomy, hypertensive patients, and patients who failed previous therapy with Viagra) and two age groups (< 65 and > 65 years) in the IIEF EF domain scores.
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