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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

Page last updated: August 23, 2015

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