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

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ClinicalTrials.gov Identifier: NCT00313898
Recruitment Status : Unknown
Verified April 2006 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : April 12, 2006
Last Update Posted : May 17, 2007
Sponsor:
Collaborator:
Pfizer
Information provided by:
Rambam Health Care Campus

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.


Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: sildenafil (viagra) Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : September 2005
Estimated Study Completion Date : June 2007

Resource links provided by the National Library of Medicine





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

Secondary Outcome Measures :
  1. changes in scoring of erectile function domain


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313898


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

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ClinicalTrials.gov Identifier: NCT00313898     History of Changes
Other Study ID Numbers: viagracommCTIL
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: May 17, 2007
Last Verified: April 2006

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

Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents