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

May 16, 2007 updated by: Rambam Health Care Campus

The Effect of Treatment for ED on Quality of Life and Satisfaction in a Group of Patients Without Prior Complaints of Sexual Dysfunction

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Recruiting
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
changes in scoring of quality of sexual life questionnaires before vs after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
changes in scoring of erectile function domain

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rambam Health Care Campus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ilan Gruenwald, MD, Israel Urology Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2005

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • viagracommCTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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