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Sponsored by: |
Rambam Health Care Campus |
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Information provided by: | Rambam Health Care Campus |
ClinicalTrials.gov Identifier: | NCT00498680 |
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 |
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 |
Estimated Enrollment: | 45 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | December 2007 |
Ages Eligible for Study: | 35 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ilan gruenwald, MD | 00972544474341 | i_gruenwald@rambam.health.gov.il |
Contact: Yoram Vardi, Prof | 0097248542819 | yvardi@rambam.health.gov.il |
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 |
Principal Investigator: | Ilan Gruenwald, MD | Israel Urology Association |
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 |
Erectile Dysfunction Treatment PDE5i |
Sexual Dysfunctions, Psychological Vardenafil Sexual Dysfunction, Physiological Mental Disorders |
Sildenafil Genital Diseases, Male Erectile Dysfunction |
Sexual Dysfunctions, Psychological Sexual Dysfunction, Physiological Mental Disorders |
Genital Diseases, Male Sexual and Gender Disorders Erectile Dysfunction |