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Published on: June 6, 2018
On-demand IC351 (Cialis) enhances erectile function in patients with erectile dysfunction
H Padma-Nathan1, J G McMurray, W E Pullman
1Keck School of Medicine, University of Southern California, Los Angeles, California 90212, USA.
On-demand tadalafil (IC351), a PDE5 inhibitor, effectively improved erectile function in men. This erectile dysfunction treatment was well-tolerated across tested doses, showing significant efficacy.
Area of Science:
- Pharmacology
- Urology
Background:
- Erectile dysfunction (ED) is a common condition affecting men's sexual health.
- Phosphodiesterase type 5 (PDE5) inhibitors are a primary treatment for ED.
Purpose of the Study:
- To assess the efficacy and safety of on-demand tadalafil (IC351) in men with ED.
- To evaluate different dosage regimens of IC351 for ED treatment.
Main Methods:
- A multicenter, double-blind, placebo-controlled study.
- 179 men with ED were randomized to placebo or IC351 (2, 5, 10, or 25 mg) on demand over 3 weeks.
- Primary endpoints: changes in International Index of Erectile Function (IIEF) Questions 3 and 4.
Main Results:
- IC351 significantly improved IIEF Q3 scores at all doses compared to placebo (P <= 0.003).
- IC351 significantly improved IIEF Q4 scores at doses above 2 mg (P <= 0.0003).
- No significant changes in vital signs or lab values; common adverse events were headache and dyspepsia.
Conclusions:
- On-demand IC351 (tadalafil) up to 25 mg is well-tolerated.
- IC351 demonstrates significant efficacy in improving erectile function for men with ED.
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