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Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males
This study is currently recruiting participants.
Verified by Rambam Health Care Campus, April 2006
Sponsors and Collaborators: Rambam Health Care Campus
Pfizer
Information provided by: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00313898
  Purpose

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.


Condition Intervention Phase
Erectile Dysfunction
Drug: sildenafil (viagra)
Phase IV

MedlinePlus related topics: Erectile Dysfunction
Drug Information available for: Sildenafil citrate Sildenafil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title: The Effect of Treatment for ED on Quality of Life and Satisfaction in a Group of Patients Without Prior Complaints of Sexual Dysfunction

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • changes in scoring of quality of sexual life questionnaires before vs after treatment

Secondary Outcome Measures:
  • changes in scoring of erectile function domain

Estimated Enrollment: 100
Study Start Date: September 2005
Estimated Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313898

Contacts
Contact: Ilan Gruenwald, MD 00972-4-8542819 ext 882 i_gruenwald@rambam.health.gov.il
Contact: Yoram Vardi, Prof 00972-4-8542819 yvardi@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Pfizer
Investigators
Principal Investigator: Ilan Gruenwald, MD Israel Urology association
  More Information

Study ID Numbers: viagracommCTIL
Study First Received: April 10, 2006
Last Updated: May 16, 2007
ClinicalTrials.gov Identifier: NCT00313898  
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
quality of sexual life, Mild erectile dysfunction

Study placed in the following topic categories:
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Mental Disorders
Quality of Life
Sildenafil
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:
Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Cardiovascular Agents
Sexual and Gender Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009