Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males

NCT ID: NCT00313898

Last Updated: 2007-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-06-30

Brief Summary

In clinical practice it is quite common to have sexually active male patients with mild/normal erectile function that are not satisfied with their sexual function. The aim of this study is to evaluate the effect of sildenafil on the quality of sexual function in this group of patients.

The endpoint of this study is to define another, different group of patients that may respond positively to treatment with sildenafil.

Detailed Description

This will be a prospective, placebo-controlled, double blind crossover study. One hundred males between 35-70 years of age in good general health will be included. Recruitment of patients will be done through patient referral to the "male sexual dysfunction clinic" at Rambam Medical Center, as well as by other necessary ways for optimal and rapid recruitment (media advertisement, direct contact with primary clinics etc.).

For each patient, the study will terminate after a maximal period of 4 months from initiation and will include 4 visits:

On inclusion (Visit I), a thorough explanation will be given to each patient on the aims and course of the study, as well as a full explanation on dosage, mode of administration, safety and efficacy of Viagra. After reading and signing an informed consent, each patient will be asked to fill a questionnaire regarding his sexual function (IIEF-ED Domain). If the patient fits inclusion criteria, he will be referred to the urologist to initiate the study. On the second encounter (Visit II), medical history and physical exam will be performed. The subject will then fill out 3 questionnaires: IIEF (full version), QVS (quality of sexual life questionnaire) and the SEARS questionnaire. Administration of medication will be performed in a double-blinded crossover fashion. Each patient will be provided, at random either 6 tablets of placebo or Viagra 50mg. The patient will be advised to use them on demand. After consuming all 6 tablets, a third visit will be scheduled. On the third visit (Visit III) each patient will be provided with new IIEF (full version), QVS (quality of sexual life questionnaire), the SEARS questionnaire and an EDITS questionnaire. A few other questions on satisfaction will be asked and recorded (questions on the quality of the erection, duration of intercourse, number of sexual acts per night, frequency of intercourse/week, satisfaction from intercourse etc). Each subject will receive another 6 tablets (Viagra/ placebo). Finally, at the last visit (Visit IV) subjects will again fill out the same questionnaires as on visit III. At the end of the study, double-blind codes will be opened and multi-variant analysis of the data will be performed using chi square and annova.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

sildenafil (viagra)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Sexually active males.
• All males between 35-70 years of age that previously have not taken any PDE5 inhibitors.
• A score of 22/30 and above of the International Index of Erectile Function (IIEF) ED domain (questions 1,2,3,4,5,15) .

Exclusion Criteria

• Patients with psychiatric disorders
• Patients with contraindications to sildenafil (patients on nitrate prescription, very low blood pressure, multiple anti-hypertensive medications, allergy to PDE5i, severe renal or hepatic insufficiency etc)
• Patients with a severe coronary artery disease
• Patients with premature ejaculation as their primary problem without a current partner.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Principal Investigators

Ilan Gruenwald, MD

Role: PRINCIPAL_INVESTIGATOR

Israel Urology association

Locations

Rambam Health Care Campus

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ilan Gruenwald, MD

Role: CONTACT

i_gruenwald@rambam.health.gov.il

00972-4-8542819 ext. 882

Yoram Vardi, Prof

Role: CONTACT

yvardi@rambam.health.gov.il

00972-4-8542819

Other Identifiers

viagracommCTIL

Identifier Type: -

Identifier Source: org_study_id