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

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 |

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 |
- increase of 5 points or more in the IIEF erectile function domain [ Time Frame: 1 month ]

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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 |
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.

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
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 |
Responsible Party: | Prof. Vardi Yoram, RAMBAM HEALTH CARE CAMPUS |
ClinicalTrials.gov Identifier: | NCT00498680 |
Other Study ID Numbers: |
2431-ctil |
First Posted: | July 10, 2007 Key Record Dates |
Last Update Posted: | October 22, 2010 |
Last Verified: | January 2007 |
Erectile Dysfunction Treatment PDE5i |
Erectile Dysfunction Sexual Dysfunction, Physiological 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 |