Erectile DysfunctionPhase 3URO2010NCT01315262
On Demand Versus Daily Sildenafil for Patients Undergoing Radical Prostatectomy
A Phase 3 study testing Sildenafil in people with Erectile Dysfunction, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
Viagra (Sildenafil citrate) is an orally active selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) which is used for the treatment of erectile dysfunction (ED). Objectives: To test the efficacy of Viagra 100mg on demand vs. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Sildenafil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2011to Dec 2012
- Phase
- Phase 3
- 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have given written informed consent to participate in the study.
- Men aged 18-65 years old.
- Weight range 50-100 Kg.
- Subjects must be in a stable relationship with the same partner for at least 6 months and willing to attempt sexual intercourse.
- Normal pre-operative erectile function (defined as IIEF-EF ≥ 26) without the use of therapy or devices for the improvement of erections.
- Prostatic Specific Antigen (PSA) lower than 10 ng/ml.
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- Clinical prostate cancer stage T1c or T2.
- Biopsy Gleason sum < 8.
- Able to read, understand and provide signed informed consent.
- Intra-operative inclusion criteria:
- Bilateral nerve sparing radical prostatectomy (both open and robotic assisted radical prostatectomy are accepted) as defined by the surgeon.
- Post-operative inclusion criteria:
- Histologically-confirmed, organ-confined prostate cancer disease (defined as, Gleason 6 or 7 and, pathological stage T2 or T3a R0 N0).
Who cannot join
- Subjects presenting with any of the following will not be included in the trial:
- Subjects in whom sexual activity is inadvisable in the opinion of the investigator such as significant cardiovascular disease in the last 6 months; including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation.
- Subjects who have a medical history of major hematological, renal, vascular or hepatic abnormalities, those with psychological or social circumstances that would impair their ability to participate reliably in the study, or those who may increase the risk to themselves or others by participating in the study.
- Subjects who have a medical history of diabetes.
- Subjects who developed a postoperative complication, namely reoperation for hemorrhage, a documented urinary fistula or the indwelling of catheter for 3 or more weeks.
- Subjects treated with neo-adjuvant radiotherapy or hormonotherapy.
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- Subjects who have received or are receiving any PDE5 inhibitors.
- Subjects with known hypersensitivity to Viagra or any component of the study medication.
- Subjects with resting sitting hypotension (BP < 90/50 mmHg), hypertension (BP > 170/110 mmHg) or orthostatic hypotension.
- Subjects with severe hepatic; cirrhosis or ALT (Alanine aminotransferase) 2x upper limit of normal) and renal impairment (creatinine clearance 30mL/min) or known history of hereditary degenerative retinal disorders such as retinitis pigmentosa.
- Subjects who, for medical reasons and/or in the opinion of the investigator, require starting dose of 25mg of Viagra.
- Subjects who are currently taking or are likely to be treated with nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or as aerosols) on either regular or intermittent basis.
- Subjects who are receiving concomitant treatment or who during the study are likely to start the treatment with potent CYP3A4 and CYP2C9 inhibitors (e.g. protease inhibitors ritonavir and saquinavir, ketoconazole, itraconazole, Miconazole, nefazadone, claritromycin, troleandomycin erythromycin and cimetidine).
- Subjects who are currently using any commercially available treatments or non-commercial herbal preparations for erectile dysfunction, e.g. IC injections, vacuum devices, or testosterone patches. Such treatments/devices must not be used at any time during the study.
- Subjects who have received any investigational drug within the six weeks prior to screening or who are taking any other investigational drug concomitantly.
- previous prostate surgery or previous hormonal treatment.
- Subjects at increased risk of priapism e.g. sickle cell disease, multiple myeloma, or with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease) and myeloproliferative disorders (e.g. myeloid leukemia, polycythemia, thrombocytopenia).
- Subjects with other forms of sexual dysfunction (e.g. retrograde ejaculation, unejaculation, painful ejaculation, premature ejaculation, hypoactive sexual desire and inhibited or absent orgasm).
- Subjects who, in the opinion of the investigator, abuse alcohol or drugs.
- Subjects who, in the opinion of the investigator, are not likely to complete the event logs and follow study instructions.
- Subjects who, in the opinion of the investigator, are not likely to complete the study for whatever reason.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Vita-Salute San Raffaele
Milan, 20132
francesco montorsi, MD, 00390226437268, montorsi.francesco@hsr.it
About this study
Official title: On Demand Versus Daily Sildenafil for Patients Undergoing Bilateral Nerve Sparing Radical Prostatectomy: a Randomized, Open Label, Parallel Group Trial
Viagra (Sildenafil citrate) is an orally active selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) which is used for the treatment of erectile dysfunction (ED). Objectives:
- To test the efficacy of Viagra 100mg on demand vs. Viagra 100mg daily (taken either at bedtime or 1 hour prior to sexual intercourse) in restoring erectile function following radical prostatectomy.
- To test the safety and tolerability of Viagra 100 mg on demand vs. Viagra 100 mg daily after radical prostatectomy.
- Conditions
- Erectile Dysfunction
- Being tested
- Sildenafil
- Keywords
- Sildenafil 100, restoring erectile function after radical prostatectomy
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
1:1 Viagra 100 mg daily (taken either at bedtime - if sexual intercourse is not expected - or 1 hour prior to sexual intercourse, no more than one 100 mg dose of sildenafil per day) vs. Viagra 100mg OD (i.e. one hour prior to sexual intercourse)
| Study group | Role | What they receive |
|---|---|---|
| Viagra 100 mg daily | Active comparator | Not described Receives: Drug: Sildenafil |
| Viagra 100mg on demand | Active comparator | Not described Receives: Drug: Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with an Erectile Function domain score of International Index of Erectile Function ( IIEF) => 22 at the end of the wash-out period (44 wks after surgery)
Measured: 44 wks after surgery
Secondary outcomes (2)
Proportion of patients with an Erectile Function domain score of IIEF => 22 at the end of the study (52 wks after surgery)
Measured: 52 wks after surgery
IIEF - Domain Scores for: Erection Hardness Score (1-4) Intercourse success rates defined by the Sexual Encounter Profile (SEP) questionnaire (questions 2 and 3) Safety Endpoints: Adverse event summarized Global assessment questions
Responses to IIEF - Domain Scores for:
- Erectile Function
- Orgasmic Function
- Sexual Desire
- Intercourse Satisfaction
- Overall Satisfaction c. Erection Hardness Score
- Intercourse success rates defined by the SEP questionnaire (questions 2 and 3)
- Safety Endpoints: Adverse event data will be summarized
- Global assessment questions:
Measured: 3-6-9-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Investigators
- francesco montorsi, MD, Principal investigator, Vita-Salute San Raffaele Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315262
- Sponsor's protocol ID
- HSR Urology
- Acronym
- URO2010
- Status last verified
- Feb 2011
- First submitted
- 14 Mar 2011
- Last updated
- 29 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On Demand Versus Daily Sildenafil for Patients Undergoing Bilateral Nerve Sparing Radical Prostatectomy: a Randomized, Open Label, Parallel Group Trial
- ClinicalTrials.gov ID
- NCT01315262
- Acronym / sponsor ID
- URO2010 / HSR Urology
- Conditions
- Erectile Dysfunction
- Keywords
- Sildenafil 100, restoring erectile function after radical prostatectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 15 Mar 2011 (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.
Viagra (Sildenafil citrate) is an orally active selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) which is used for the treatment of erectile dysfunction (ED). Objectives:
- To test the efficacy of Viagra 100mg on demand vs. Viagra 100mg daily (taken either at bedtime or 1 hour prior to sexual intercourse) in restoring erectile function following radical prostatectomy.
- To test the safety and tolerability of Viagra 100 mg on demand vs. Viagra 100 mg daily after radical prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viagra 100 mg daily | Active comparator | Drug: Sildenafil |
| Viagra 100mg on demand | Active comparator | Drug: Sildenafil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects who have given written informed consent to participate in the study.
- Men aged 18-65 years old.
- Weight range 50-100 Kg.
- Subjects must be in a stable relationship with the same partner for at least 6 months and willing to attempt sexual intercourse.
- Normal pre-operative erectile function (defined as IIEF-EF ≥ 26) without the use of therapy or devices for the improvement of erections.
Key exclusion criteria (21 listed)
- Subjects in whom sexual activity is inadvisable in the opinion of the investigator such as significant cardiovascular disease in the last 6 months; including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation.
- Subjects who have a medical history of major hematological, renal, vascular or hepatic abnormalities, those with psychological or social circumstances that would impair their ability to participate reliably in the study, or those who may increase the risk to themselves or others by participating in the study.
- Subjects who have a medical history of diabetes.
- Subjects who developed a postoperative complication, namely reoperation for hemorrhage, a documented urinary fistula or the indwelling of catheter for 3 or more weeks.
- Subjects treated with neo-adjuvant radiotherapy or hormonotherapy.
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 |
|---|---|---|
| Sildenafil1:1 Viagra 100 mg daily (taken either at bedtime - if sexual intercourse is not expected - or 1 hour prior to sexual intercourse, no more than one 100 mg dose of sildenafil per day) vs. Viagra 100mg OD (i.e. one hour prior to sexual intercourse) | Drug | Viagra 100 mg daily, Viagra 100mg on demand |
Primary outcome
Proportion of patients with an Erectile Function domain score of International Index of Erectile Function ( IIEF) => 22 at the end of the wash-out period (44 wks after surgery)
Time frame: 44 wks after surgery
2 secondary outcomes
Proportion of patients with an Erectile Function domain score of IIEF => 22 at the end of the study (52 wks after surgery)
Time frame: 52 wks after surgery
IIEF - Domain Scores for: Erection Hardness Score (1-4) Intercourse success rates defined by the Sexual Encounter Profile (SEP) questionnaire (questions 2 and 3) Safety Endpoints: Adverse event summarized Global assessment questions
Time frame: 3-6-9-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2011.
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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.
francesco montorsi, MD principal investigator
Vita-Salute San Raffaele Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil in people with Erectile Dysfunction, run by Università Vita-Salute San Raffaele at 1 site in Italy.
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 13 inclusion and 21 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 29 Mar 2011. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with an Erectile Function domain score of International Index of Erectile Function ( IIEF) => 22 at the end of the wash-out period (44 wks after surgery) (time frame: 44 wks after surgery). 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 29 Mar 2011.