NCT01364701

Evaluation of Safety and Effectiveness of 2 Lower Dose Combined PDE5i's Versus Single Maximal Dose PDE5i Treatment

A Prospective, Randomized, 3-arm Parallel Trial to Evaluate the Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i Treatment

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Clinical effectiveness is of the finest tools to evaluate treatment success and is combined of 3 elements: treatment effectivity, side effect profile and patient compliance. Since the 3 main PDE5i's differ in their molecular structure, therapeutic profile and pharmacokinetics, it seems logical to assume that combining 2 different PDE5i's at lower dosage each may be beneficial in comparison to a single PDE5i maximal dose therapy. The aim of this study is to compare the clinical effectiveness of combination therapy (2 lower-dose PDE5i's) versus single maximal dose PDE5i therapy.

Detailed description

This will be a prospective, randomized, 3-arm parallel trial on 60 males with erectile dysfunction (ED) that have never been exposed to PDE5i therapy (naïve patients) will be enrolled. In each group, every patient will receive three treatment regimes (Viagra®50mg \& Cialis®10mg, Viagra®100mg, Cialis®20mg), in different sequences of administration.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Sildenafil 100 mg	4 tablets for on demand use
DRUG	Tadalafil 20 mg	4 tablets on demand
DRUG	Combination half of maximal dose for sildenafil & tadalafil	4 tablets on demand

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-06-01
• Completion: 2012-07-01
• First posted: 2011-06-02
• Last updated: 2011-06-20

Locations

1 site across 1 country: Israel