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

Erectile Dysfunction Clinical Trial

— PDE5i  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01364701
• Other study ID #: 0449-10-RMB
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 18, 2011
• Last updated: June 17, 2011
• Start date: June 2011
• Est. completion date: July 2012

Study information

• Verified date: April 2011
• Source: Rambam Health Care Campus
• Contact: Ilan Gruenwald, MD
• Phone: 0097248542882
• Email: i_gruenwald[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 75 Years

Eligibility

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.).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Sildenafil 100 mg
4 tablets for on demand use
• Tadalafil 20 mg
4 tablets on demand
• Combination half of maximal dose for sildenafil & tadalafil
4 tablets on demand

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Erection Hardness Scale	At each visit after use of different treatment each time	Each visit- altogether 3 months	No