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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: Sildenafil 100 mg
* Drug: Tadalafil 20 mg
* Drug: Combination half of maximal dose for sildenafil & tadalafil


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Maximal dose sildenafil<br>4 tablets of sildenafil 100mg are given for on demand use | Drug: Sildenafil 100 mg<br>* 4 tablets for on demand use<br>* Other names: Viagra;|
| Active Comparator: Tadalafil 20mg maximal dose<br>4 tablets of tadalafil 20mg are given for on demand use | Drug: Tadalafil 20 mg<br>* 4 tablets on demand<br>* Other names: Cialis;|
| Active Comparator: Combination half dose<br>4 tablets of sildenafil 50mg and tadalafil 10mg are given for on demand use | Drug: Combination half of maximal dose for sildenafil & tadalafil<br>* 4 tablets on demand<br>* Other names: Combination;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile Function-Erectile Dysfunction (IIEF-ED) Domain Score | At each visit after use of different treatment each time | Every visit- altogether 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erection Hardness Scale | At each visit after use of different treatment each time | Each visit- altogether 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile dysfunction, combination therapy, Sildenafil, tadalafil, PDE5i, No Conditions