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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01364701
First received: May 18, 2011
Last updated: June 17, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Erectile Dysfunction
Drug: Sildenafil 100 mg
Drug: Tadalafil 20 mg
Drug: Combination half of maximal dose for sildenafil & tadalafil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • International Index of Erectile Function-Erectile Dysfunction (IIEF-ED) Domain Score [ Time Frame: Every visit- altogether 3 months ] [ Designated as safety issue: No ]
    At each visit after use of different treatment each time


Secondary Outcome Measures:
  • Erection Hardness Scale [ Time Frame: Each visit- altogether 3 months ] [ Designated as safety issue: No ]
    At each visit after use of different treatment each time


Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Combination

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

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364701

Contacts
Contact: Ilan Gruenwald, MD 0097248542882 i_gruenwald@rambam.health.gov.il
Contact: Yoram Vardi, Prof. 0097248542819 yvardi@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Not yet recruiting
Haifa, Israel
Contact: Ilan Gruenwald, MD    0097248542882    i_gruenwald@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Yoram Vardi, Prof. Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Ilan Gruenwald MD, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01364701     History of Changes
Other Study ID Numbers: 0449-10-RMB
Study First Received: May 18, 2011
Last Updated: June 17, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Erectile dysfunction
combination therapy
Sildenafil
tadalafil
PDE5i
No Conditions

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual and Gender Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sildenafil
Tadalafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 21, 2014