Erectile DysfunctionPhase 4NCT00313898
Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males
A Phase 4 study testing sildenafil (viagra) in people with Erectile Dysfunction, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- sildenafil (viagra)
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2005to Jun 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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) .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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
- Being tested
- sildenafil (viagra)
- Keywords
- quality of sexual life, Mild erectile dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafil (viagra)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in scoring of quality of sexual life questionnaires before vs after treatment
Secondary outcomes (1)
changes in scoring of erectile function domain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startSep 2005
- Study completionJun 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Ilan Gruenwald, MD, Principal investigator, Israel Urology association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313898
- Sponsor's protocol ID
- viagracommCTIL
- Status last verified
- Apr 2006
- First submitted
- 10 Apr 2006
- Last updated
- 17 May 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00313898
- Acronym / sponsor ID
- viagracommCTIL
- Conditions
- Erectile Dysfunction
- Keywords
- quality of sexual life, Mild erectile dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Sep 2005
- Study completion
- Jun 2007 (estimated)
- First posted
- 12 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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) .
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sildenafil (viagra) | Drug | – |
Primary outcome
changes in scoring of quality of sexual life questionnaires before vs after treatment
1 secondary outcome
changes in scoring of erectile function domain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilan Gruenwald, MD principal investigator
Israel Urology association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sildenafil (viagra) in people with Erectile Dysfunction, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilan Gruenwald, MD (00972-4-8542819 ext. 882, i_gruenwald@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in scoring of quality of sexual life questionnaires before vs after treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2007.