Topical alprostadil cream for the treatment of erectile dysfunction: a combined analysis of the phase II program
| Autor: | Christopher P. Steidle, Natalie Tayse, Denise Thwing, Shawki Salem, Harin Padma-Nathan, Jane Fendl, James Yeager, Ronald Harning |
|---|---|
| Rok vydání: | 2002 |
| Předmět: |
Adult
Male medicine.medical_specialty Administration Topical Vasodilator Agents Urology Physical examination Placebo law.invention Clinical Trials Phase II as Topic Erectile Dysfunction Randomized controlled trial law medicine Humans Alprostadil Adverse effect Aged Analysis of Variance medicine.diagnostic_test business.industry Middle Aged medicine.disease Surgery Clinical trial Erectile dysfunction Meta-analysis Anesthesia Analysis of variance business |
| Zdroj: | Urology. 60:1077-1082 |
| ISSN: | 0090-4295 |
| Popis: | Objectives To present a meta-analysis of the efficacy and safety data of two recently completed Phase II studies examining a novel alprostadil topical cream for the treatment of erectile dysfunction (ED). Methods Patients (n = 303) with ED of at least 3 months’ duration were randomized to receive placebo or 50, 100, 200, or 300 μg alprostadil in two nearly identical 11-dose, multicenter, at-home studies of a novel topical cream containing alprostadil and a proprietary skin permeation enhancer. The primary efficacy endpoint was the change in erectile function domain score from baseline to the final visit. Secondary endpoints included changes in scores for questions 3 and 4 of the International Index of Erectile Function and standard diary analyses. Safety was assessed by analysis of adverse events, changes in laboratory test results, and physical examination findings. Results The mean baseline parameters for the erectile function score, ED history, and secondary diagnoses suggested no significant differences among the treatment groups. The changes from baseline to the final visit erectile function scores were 0.98 ± 0.84, 3.4 ± 1.3, 3.4 ± 0.88 (P |
| Databáze: | OpenAIRE |
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