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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Eli Lilly and Company (NYSE: LLY) announced results from a double-blind, placebo-controlled study which showed that tadalafil 5 mg dose taken once daily was generally well-tolerated, improved erectile function for men with erectile dysfunction (ED) and reported improvement in the sexual quality of life scores for men and their female partners. The 12-week study monitored 342 men and their partners, using several scientific questionnaires to assess changes in erectile function and sexual quality of life before and after treatment with a tadalafil once daily dose. The study appears in the May issue of the peer-reviewed Journal of Sexual Medicine.
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