Dong-A Pharmaceutical Co., Ltd. and Dong-A PharmTech, Co. Ltd. announced that it has completed a 240 patient once-a-day dosing clinical study of udenafil, its new long acting phosphodiesterase type 5 (PDE-5) inhibitor for erectile dysfunction (ED). The multi-center study conducted in Korea was a randomized, double-blind, placebo-controlled study, designed to investigate the efficacy and safety of udenafil in patients with ED. Following a 4-week non-drug baseline period, 240 men with ED of broad etiology and severity were randomized to one of four treatment groups: Placebo, udenafil 25 mg, udenafil 50 mg or udenafil 75 mg. Patients took one tablet a day for 12 weeks with evaluations every 4 weeks. The primary efficacy endpoint was the change in the standard International Index of Erectile Function (IIEF) Erectile Function Domain (EF) score from baseline to final visit. The secondary efficacy endpoints were the change from the baseline in the mean vaginal penetration success rates and mean intercourse completion rates calculated from the Sexual Encounter Profile (SEP) questions 2 and 3. In addition a sub-group analysis was conducted to determine efficacy in the patients that had lower urinary tract symptoms associated with benign prostatic hyperplasia in addition to erectile dysfunction.
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UroToday.com – Most recently, health-related quality-of-life (HRQOL) after definitive local therapy for prostate cancer has been argued in the patient group with an oncological risk category. [1] Prior to such controversy, we thought that posttreatment HRQOL issues or functional outcomes possibly vary among oncological risk categories, and compared both oncological and functional outcomes between patients receiving radical prostatectomy (RP) and those undergoing external beam radiation therapy (EBRT) with risk stratification. [2] Indeed, we found that the low- and intermediate-risk patients in the RP group reported poorer urinary function than those in the EBRT group.
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Sciele Pharma Inc., a Shionogi Company, and Plethora Solutions Holdings PLC (”Plethora” – AIM:PLE), announced that a second and final Phase III double-blind, placebo-controlled study of PSD502 for the treatment of premature ejaculation (’PE’) has met all co-primary endpoints of Intra-vaginal Ejaculation Latency Time (’IELT’), Index of Premature Ejaculation (’IPE,’ Ejaculatory Control, Sexual Satisfaction and Distress domains).

This successful study, involving patients from the USA, Canada and Europe, is one of two pivotal Phase III studies that were run in parallel with identical protocols. The previously announced Phase III study was conducted entirely in Europe, and its successful outcome was reported in November 2008. Data from the two studies will be combined for submission for regulatory approval in the USA and Europe.
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