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

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Unknown status

CT.gov ID

NCT01364701

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Sildenafil 100 mg Drug: Tadalafil 20 mg Drug: Combination half of maximal dose for sildenafil & tadalafil	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2011

Anticipated Primary Completion Date :

Jun 1, 2012

Anticipated Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Maximal dose sildenafil 4 tablets of sildenafil 100mg are given for on demand use	Drug: Sildenafil 100 mg 4 tablets for on demand use Other Names: Viagra
Active Comparator: Tadalafil 20mg maximal dose 4 tablets of tadalafil 20mg are given for on demand use	Drug: Tadalafil 20 mg 4 tablets on demand Other Names: Cialis
Active Comparator: Combination half dose 4 tablets of sildenafil 50mg and tadalafil 10mg are given for on demand use	Drug: Combination half of maximal dose for sildenafil & tadalafil 4 tablets on demand Other Names: Combination

Arm

Intervention/Treatment

Active Comparator: Maximal dose sildenafil

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

Drug: Sildenafil 100 mg

4 tablets for on demand use

Other Names:

Viagra

Active Comparator: Tadalafil 20mg maximal dose

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

Drug: Tadalafil 20 mg

4 tablets on demand

Other Names:

Cialis

Active Comparator: Combination half dose

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

Drug: Combination half of maximal dose for sildenafil & tadalafil

4 tablets on demand

Other Names:

Combination

Outcome Measures

Primary Outcome Measures

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

Erection Hardness Scale [Each visit- altogether 3 months]
At each visit after use of different treatment each time

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts 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.).