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
Recruitment status was Recruiting
Sponsor:
Rambam Health Care Campus
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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
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:
|
Sildenafil Vardenafil Cardiovascular Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Therapeutic Uses Urological Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on March 01, 2015