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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01364701

Acronym

PDE5i

Enrollment

Registered

2011-06-02

Start date

2011-06-30

Completion date

2012-07-31

Last updated

2011-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunction, combination therapy, Sildenafil, tadalafil, PDE5i, No Conditions

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.

Interventions

DRUGSildenafil 100 mg

4 tablets for on demand use

DRUGTadalafil 20 mg

4 tablets on demand

DRUGCombination half of maximal dose for sildenafil & tadalafil

4 tablets on demand

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

35 Years to 75 Years

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.).

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Israel

Contacts

Primary ContactIlan Gruenwald, MD

i_gruenwald@rambam.health.gov.il0097248542882

Backup ContactYoram Vardi, Prof.

yvardi@rambam.health.gov.il0097248542819

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026