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

Rambam Health Care Campus

Status and phase: Unknown; Phase 4

Conditions: Erectile Dysfunction

Treatments: Drug: Combination half of maximal dose for sildenafil & tadalafil; Drug: Tadalafil 20 mg; Drug: Sildenafil 100 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01364701

0449-10-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

Maximal dose sildenafil

Active Comparator group

Description:

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

Treatment:

Drug: Sildenafil 100 mg

Tadalafil 20mg maximal dose

Active Comparator group

Description:

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

Treatment:

Drug: Tadalafil 20 mg

Combination half dose

Active Comparator group

Description:

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

Treatment:

Drug: Combination half of maximal dose for sildenafil & tadalafil