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

This study is currently recruiting participants.

Verified by Rambam Health Care Campus, January 2007

First Received: July 8, 2007 Last Updated: July 9, 2007 History of Changes

Sponsored by:	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: Sildenafi (Viagra), Vardenafil (Levitra)	Phase IV

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:

Safety- Decrease of 20 mmhg and above in systolic or dioastolic blood pressure up to 5 hours (measuring every hour) after half dose combination intake.
Efficacy- Significant questionnaire scores compared between all 3 groups.

Estimated Enrollment:	45
Study Start Date:	March 2007
Estimated Study Completion Date:	December 2007

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

Study ID Numbers:	2431-ctil
Study First Received:	July 8, 2007
Last Updated:	July 9, 2007
ClinicalTrials.gov Identifier:	NCT00498680 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:

Erectile Dysfunction
Treatment
PDE5i

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Vardenafil
Sexual Dysfunction, Physiological
Mental Disorders

Sildenafil
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Mental Disorders

Genital Diseases, Male
Sexual and Gender Disorders
Erectile Dysfunction

ClinicalTrials.gov processed this record on May 07, 2009