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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-07-31

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.

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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.

Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Maximal dose sildenafil

4 tablets of sildenafil 100mg are given for on demand use

Group Type ACTIVE_COMPARATOR

Sildenafil 100 mg

Intervention Type DRUG

4 tablets for on demand use

Tadalafil 20mg maximal dose

4 tablets of tadalafil 20mg are given for on demand use

Group Type ACTIVE_COMPARATOR

Tadalafil 20 mg

Intervention Type DRUG

4 tablets on demand

Combination half dose

4 tablets of sildenafil 50mg and tadalafil 10mg are given for on demand use

Group Type ACTIVE_COMPARATOR

Combination half of maximal dose for sildenafil & tadalafil

Intervention Type DRUG

4 tablets on demand

Interventions

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Sildenafil 100 mg

4 tablets for on demand use

Intervention Type DRUG

Tadalafil 20 mg

4 tablets on demand

Intervention Type DRUG

Combination half of maximal dose for sildenafil & tadalafil

4 tablets on demand

Intervention Type DRUG

Other Intervention Names

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Viagra Cialis Combination

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.).

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No