Evaluation of Safety and Effectiveness of 2 Lower Dose Combined PDE5i's Versus Single Maximal Dose PDE5i Treatment
PDE5i
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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJune 20, 2011
April 1, 2011
1 year
May 18, 2011
June 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Erection Hardness Scale
Each visit- altogether 3 months
Study Arms (3)
Maximal dose sildenafil
ACTIVE COMPARATOR4 tablets of sildenafil 100mg are given for on demand use
Tadalafil 20mg maximal dose
ACTIVE COMPARATOR4 tablets of tadalafil 20mg are given for on demand use
Combination half dose
ACTIVE COMPARATOR4 tablets of sildenafil 50mg and tadalafil 10mg are given for on demand use
Interventions
4 tablets on demand
Eligibility Criteria
You may qualify if:
- Age ranging between 35-75 years.
- Sexually active
- IIEF ED domain score 22 and below
You may not qualify if:
- 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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rambam Health Care Campus
Haifa, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yoram Vardi, Prof.
Rambam Health Care Campus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 18, 2011
First Posted
June 2, 2011
Study Start
June 1, 2011
Primary Completion
June 1, 2012
Study Completion
July 1, 2012
Last Updated
June 20, 2011
Record last verified: 2011-04