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Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i

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ClinicalTrials.gov Identifier: NCT00498680
Recruitment Status : Unknown
Verified January 2007 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : July 10, 2007
Last Update Posted : October 22, 2010
Sponsor:
Information provided by:
Rambam Health Care Campus

Study Description
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Brief Summary:
A prospective, randomized, 3-arm parallel trial on 45 males with ED that were never exposed to PDE5i therapy (naïve patients) will be enrolled.In each group, every patient will receive three treatment regimes (Viagra®50mg & Levitra®10mg, Viagra®100mg, Levitra®20mg), in different sequences of administration in such a manner that eventually each patient will receive all regimes in a double- blinded fasion.Safety will be evaluated at pre- screening by measuring hourly vital signs (blood pressure, heart rate)for 4 consecutive hours after taking half-dose combination. Any decrease in blood pressure of 20 mmhg below baseline will exclude the subject from the study. Effcacy will be evaluated by questionnaires (IIEF, Quality of erection questionnaire, grade of erection scale, Sear, QVS and Sexual Encounter Profiles for each sexual event). Non-parametric statistical analysis of the collected data Comparing the 3 groups will be performed.

Condition or disease Intervention/treatment Phase
Impotence Drug: Sildenafil, Vardenafil Drug: Sildenafil Drug: Vardenafil Drug: Sildenafil & Vardenafil Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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
Study Start Date : March 2007
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : June 2011

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Viagra 100mg Drug: Sildenafil
100mg
Active Comparator: Levitra 20mg Drug: Vardenafil
20mg
Active Comparator: Viagra 50mg+ Levitra 10mg Drug: Sildenafil, Vardenafil
Sildenafil 100mg, vardenafil 20mg, combination of both half dosage.
Other Name: Viagra, Levitra

Drug: Sildenafil & Vardenafil
50mg & 10 mg


Outcome Measures
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Primary Outcome Measures :
  1. increase of 5 points or more in the IIEF erectile function domain [ Time Frame: 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relationship with the same partner for at least 3 month
  • Age ranging between 35-65 years old
  • Sexually active, (minimal frequency of one sexual encounter per 2 weeks)
  • IIEF ED domain score 22 and below.

Exclusion Criteria:

  • Subjects with premature ejaculation as their main sexual complaint.
  • Subjects with severe cardiovascular disease in the past 6 months, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack, symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation,
  • Subjects with Contraindications to PDE5i therapy. Namely patients receiving treatment with nitrate based medication or patients that for various reasons cannot take PDE5 inhibitors (severe hepatic diseases- cirrhosis or ALT (Alanine aminotransferase)>2x upper limit of normal), renal impairment (creatinine clearance > 30ml/min) or known hereditary degenerative retinal disorders such as retinitis pigmentosa. ,
  • Concomitant treatment with potent CYP3A4 and CYP2C9 inhibitors (e.g protease inhibitors ritonavir and saquinavir, ketoconazole, itrakonazole, miconazole, nefazodone, claritromycin, troleandomycin, erythromycin and cimetidine)
  • Subjects mentally unfit for the study.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498680


Contacts
Contact: Ilan gruenwald, MD 00972544474341 i_gruenwald@rambam.health.gov.il
Contact: Yoram Vardi, Prof 0097248542819 yvardi@rambam.health.gov.il

Locations
Israel
Neuro-urology unit, Rambam Medical Center Recruiting
Haifa, Israel, 31096
Contact: Ilan Gruenwald, MD    0097248542882    i_gruenwald@rambam.health.gov.il   
Contact: Yoram vardi, Prof    0097248542819    yvardi@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Ilan Gruenwald, MD Israel Urology Association
More Information
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Responsible Party: Prof. Vardi Yoram, RAMBAM HEALTH CARE CAMPUS
ClinicalTrials.gov Identifier: NCT00498680     History of Changes
Other Study ID Numbers: 2431-ctil
First Posted: July 10, 2007    Key Record Dates
Last Update Posted: October 22, 2010
Last Verified: January 2007

Keywords provided by Rambam Health Care Campus:
Erectile Dysfunction
Treatment
PDE5i

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Vardenafil Dihydrochloride
 Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents