Evaluation of Safety and Effectiveness of 2 Lower Dose Combined PDE5i's Versus Single Maximal Dose PDE5i Treatment
Information source: Rambam Health Care Campus
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Sildenafil 100 mg (Drug); Tadalafil 20 mg (Drug); Combination half of maximal dose for sildenafil & tadalafil (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Rambam Health Care Campus Official(s) and/or principal investigator(s): Yoram Vardi, Prof., Principal Investigator, Affiliation: Rambam Health Care Campus
Overall contact: Ilan Gruenwald, MD, Phone: 0097248542882, Email: i_gruenwald@rambam.health.gov.il
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: International Index of Erectile Function-Erectile Dysfunction (IIEF-ED) Domain Score
Secondary outcome: Erection Hardness Scale
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.
Eligibility
Minimum age: 35 Years.
Maximum age: 75 Years.
Gender(s): Female.
Criteria:
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.).
Locations and Contacts
Ilan Gruenwald, MD, Phone: 0097248542882, Email: i_gruenwald@rambam.health.gov.il
Rambam Health Care Campus, Haifa, Israel; Not yet recruiting Ilan Gruenwald, MD, Phone: 0097248542882, Email: i_gruenwald@rambam.health.gov.il
Additional Information
Starting date: June 2011
Last updated: June 17, 2011
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