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

Phase 4

• Conditions: Erectile Dysfunction
• Interventions: Drug: Tadalafil 20 mg; Drug: Sildenafil 100 mg; Drug: Combination half of maximal dose for sildenafil & tadalafil

• Registration Number: NCT01364701
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

Study Timeline

• Status Verified: 2011-04
• Study First Submitted: 2011-05-18
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-02
• Last Update Submitted: 2011-06-17
• Last Update Posted: 2011-06-20
• Primary Completion: 2012-06
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Age ranging between 35-75 years.
• Sexually active
• IIEF ED domain score 22 and below

Exclusion Criteria

• Subjects with premature ejaculation as their main sexual complaint.
• Subjects with severe cardiovascular disease
• Subjects with Contraindications to PDE5i therapy. Namely patients receiving treatment with nitrate based medication or patients that for various reasons cannot take PDE5 inhibitors (i.e severe coronary disease, liver or renal failure, concomitant medications, etc.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tadalafil 20mg maximal dose	Tadalafil 20 mg	4 tablets of tadalafil 20mg are given for on demand use
Maximal dose sildenafil	Sildenafil 100 mg	4 tablets of sildenafil 100mg are given for on demand use
Combination half dose	Combination half of maximal dose for sildenafil & tadalafil	4 tablets of sildenafil 50mg and tadalafil 10mg are given for on demand use

Primary Outcome Measures

Name	Time	Method
International Index of Erectile Function-Erectile Dysfunction (IIEF-ED) Domain Score	Every visit- altogether 3 months	At each visit after use of different treatment each time

Secondary Outcome Measures

Name	Time	Method
Erection Hardness Scale	Each visit- altogether 3 months	At each visit after use of different treatment each time

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel