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

Impotence research study

What is the primary objective of this study?

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Impotence

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Sildenafil, VardenafilSildenafil 100mg, vardenafil 20mg, combination of both half dosage.

Drug:Sildenafil100mg

Drug:Vardenafil20mg

Drug:

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Viagra 100mg

Levitra 20mg

Viagra 50mg+ Levitra 10mg

Study Status

Unknown status

Start Date: March 2007

Completed Date: June 2011

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: increase of 5 points or more in the IIEF erectile function domain

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Ilan Gruenwald, MD

Lead Sponsor: Rambam Health Care Campus

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00498680

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