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

Primary Purpose

Erectile Dysfunction

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Sildenafil 100 mg
Tadalafil 20 mg
Combination half of maximal dose for sildenafil & tadalafil
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile dysfunction, combination therapy, Sildenafil, tadalafil, PDE5i, No Conditions

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.).

Sites / Locations

  • Rambam Health Care Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Maximal dose sildenafil

Tadalafil 20mg maximal dose

Combination half dose

Arm Description

4 tablets of sildenafil 100mg are given for on demand use

4 tablets of tadalafil 20mg are given for on demand use

4 tablets of sildenafil 50mg and tadalafil 10mg are given for on demand use

Outcomes

Primary Outcome Measures

International Index of Erectile Function-Erectile Dysfunction (IIEF-ED) Domain Score
At each visit after use of different treatment each time

Secondary Outcome Measures

Erection Hardness Scale
At each visit after use of different treatment each time

Full Information

First Posted
May 18, 2011
Last Updated
June 17, 2011
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT01364701
Brief Title
Evaluation of Safety and Effectiveness of 2 Lower Dose Combined PDE5i's Versus Single Maximal Dose PDE5i Treatment
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile dysfunction, combination therapy, Sildenafil, tadalafil, PDE5i, No Conditions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maximal dose sildenafil
Arm Type
Active Comparator
Arm Description
4 tablets of sildenafil 100mg are given for on demand use
Arm Title
Tadalafil 20mg maximal dose
Arm Type
Active Comparator
Arm Description
4 tablets of tadalafil 20mg are given for on demand use
Arm Title
Combination half dose
Arm Type
Active Comparator
Arm Description
4 tablets of sildenafil 50mg and tadalafil 10mg are given for on demand use
Intervention Type
Drug
Intervention Name(s)
Sildenafil 100 mg
Other Intervention Name(s)
Viagra
Intervention Description
4 tablets for on demand use
Intervention Type
Drug
Intervention Name(s)
Tadalafil 20 mg
Other Intervention Name(s)
Cialis
Intervention Description
4 tablets on demand
Intervention Type
Drug
Intervention Name(s)
Combination half of maximal dose for sildenafil & tadalafil
Other Intervention Name(s)
Combination
Intervention Description
4 tablets on demand
Primary Outcome Measure Information:
Title
International Index of Erectile Function-Erectile Dysfunction (IIEF-ED) Domain Score
Description
At each visit after use of different treatment each time
Time Frame
Every visit- altogether 3 months
Secondary Outcome Measure Information:
Title
Erection Hardness Scale
Description
At each visit after use of different treatment each time
Time Frame
Each visit- altogether 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilan Gruenwald, MD
Phone
0097248542882
Email
i_gruenwald@rambam.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yoram Vardi, Prof.
Phone
0097248542819
Email
yvardi@rambam.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoram Vardi, Prof.
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilan Gruenwald, MD
Phone
0097248542882
Email
i_gruenwald@rambam.health.gov.il

12. IPD Sharing Statement

Learn more about this trial

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

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