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

NCT00498680 | Unknown Phase 4

• 1 other identifier: 2431-ctil
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Impotence

Keywords

Erectile Dysfunction; Treatment; PDE5i

Outcome Measures

Primary Outcomes (1)

• increase of 5 points or more in the IIEF erectile function domain

  1 month

Study Arms (3)

Viagra 100mg

ACTIVE COMPARATOR

Drug: Sildenafil

Levitra 20mg

ACTIVE COMPARATOR

Drug: Vardenafil

Viagra 50mg+ Levitra 10mg

ACTIVE COMPARATOR

Drug: Sildenafil, Vardenafil; Drug: Sildenafil & Vardenafil

Interventions

Sildenafil & Vardenafil DRUG

50mg \& 10 mg

Viagra 50mg+ Levitra 10mg

Sildenafil DRUG

100mg

Viagra 100mg

Vardenafil DRUG

20mg

Levitra 20mg

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Neuro-urology unit, Rambam Medical Center

Haifa, 31096, Israel

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate; Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Azoles

Study Officials

• Ilan Gruenwald, MD

  Israel Urology Association

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilan gruenwald, MD

CONTACT

00972544474341; i_gruenwald@rambam.health.gov.il

Yoram Vardi, Prof

CONTACT

0097248542819; yvardi@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2007
• First Posted: July 10, 2007
• Study Start: March 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 22, 2010

Record last verified: 2007-01

Locations

IL (1)