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

June 17, 2011 updated by: Rambam Health Care Campus

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 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Maximal dose sildenafil
4 tablets of sildenafil 100mg are given for on demand use
Drug: Sildenafil 100 mg
4 tablets for on demand use
Other Names:
  • Viagra
Active Comparator: Tadalafil 20mg maximal dose
4 tablets of tadalafil 20mg are given for on demand use
Drug: Tadalafil 20 mg
4 tablets on demand
Other Names:
  • Cialis
Active Comparator: Combination half dose
4 tablets of sildenafil 50mg and tadalafil 10mg are given for on demand use
Drug: Combination half of maximal dose for sildenafil & tadalafil
4 tablets on demand
Other Names:
  • Combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Index of Erectile Function-Erectile Dysfunction (IIEF-ED) Domain Score
Time Frame: Every visit- altogether 3 months
At each visit after use of different treatment each time
Every visit- altogether 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Yoram Vardi, Prof., Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

May 18, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimate)

June 2, 2011

Study Record Updates

Last Update Posted (Estimate)

June 20, 2011

Last Update Submitted That Met QC Criteria

June 17, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0449-10-RMB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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