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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2007 by Rambam Health Care Campus.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Rambam Health Care Campus

ClinicalTrials.gov Identifier:

NCT00498680

First received: July 8, 2007

Last updated: October 21, 2010

Last verified: January 2007

History of Changes

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 4


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 hydrochloride Vardenafil dihydrochloride Vardenafil hydrochloride trihydrate

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 (Adult)
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

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: 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


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 Mental Disorders Sildenafil Citrate Vardenafil Dihydrochloride	Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents

ClinicalTrials.gov processed this record on September 26, 2016

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