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

Sponsor:	Rambam Health Care Campus
Information provided by:	Rambam Health Care Campus
ClinicalTrials.gov Identifier:	NCT00498680

Purpose

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	Intervention	Phase
Impotence	Drug: Sildenafil, Vardenafil Drug: Sildenafil Drug: Vardenafil Drug: Sildenafil & Vardenafil	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Sildenafil Sildenafil citrate Vardenafil Vardenafil dihydrochloride

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:

increase of 5 points or more in the IIEF erectile function domain [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	46
Study Start Date:	March 2007
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Show Detailed Description

Eligibility

Ages Eligible for Study:	35 Years to 65 Years
Genders 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

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

No publications provided

Responsible Party:	Prof. Vardi Yoram, RAMBAM HEALTH CARE CAMPUS
ClinicalTrials.gov Identifier:	NCT00498680 History of Changes
Other Study ID Numbers:	2431-ctil
Study First Received:	July 8, 2007
Last Updated:	October 21, 2010
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

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
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vardenafil

Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012