Erectile DysfunctionSILOROSNCT07676617
Satisfaction of Patients With Erectile Dysfunction With the Use of Sildenafil Oral Suspension Compared to Orodispersible Tablets
An observational study of Erectile Dysfunction and Erectile Dysfunction (ED), run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The goal of this observational retrospective study is to to evaluate treatment satisfaction with sildenafil oral suspension in patients with mild-to-moderate ED who were previously taking orodispersible sildenafil. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Erectile Dysfunction, Erectile Dysfunction (ED)
- What is being tested?
- Sildenafil Oral Suspension Compared to Orodispersible Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2026to 31 Aug 2026
- Phase
- Observational
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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Data from patients with ED attending the Andrology Outpatient Clinic of the Urology Department of the IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation will be retrospectively analyzed.
Who may be able to join
- Age 18-75
- Male
- Sexually active (at least 2 sexual encounters per week)
- IIEF-EF between 11 and 25 at baseline
Who cannot join
- hypogonadism (total testosterone < 3.5 ng/mL)
- previous pelvic surgery
- ED on a neurogenic basis
- concomitant use of other ED therapies
- conical therapy with nitrates or other contraindicated drugs in combination with sildenafil
- hypersensitivity to the active ingredient
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- patients for whom sexual activity is not recommended (e.g. patients with serious cardiovascular disorders, such as unstable angina or severe heart failure).
- patients who have lost vision in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION), whether or not this event was related to previous use of a phosphodiesterase type 5 (PDE5) inhibitor
- patients with severe hepatic impairment, hypotension (blood pressure <90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal diseases, such as retinitis pigmentosa
- patients treated with guanylate cyclase stimulants, such as riociguat.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
About this study
The goal of this observational retrospective study is to to evaluate treatment satisfaction with sildenafil oral suspension in patients with mild-to-moderate ED who were previously taking orodispersible sildenafil.
The secondary objective is to evaluate the efficacy and side effects of therapy with sildenafil oral suspension compared to orodispersible sildenafil.
Patients who took sildenafil orodispersible 50 mg for 3 months and subsequently took sildenafil oral suspension for another 3 months will be enrolled.
Read the detailed description
Erectile dysfunction (ED) is a very common condition affecting approximately 50% of men over 40. Numerous studies have shown that ED has a significant negative impact on a couple's quality of life and can lead to depressive symptoms and a loss of self-esteem. The first-line treatment for ED is phosphodiesterase type 5 inhibitors (PDE5 inhibitors). In Italy, four drugs are approved for the treatment of ED: sildenafil, tadalafil, vardenafil, and avanafil, each available in different formulations and dosages. Despite the wide variety of options, the dropout rate from ED therapy is very high. This is explained by the need for personalized therapy for each ED patient and by the demands of men not met by current medications on the market. Specifically, ED patients require treatment that is spontaneous, effective, and easily adjustable. These characteristics are often not met by the formulations and dosages of PDE5 inhibitors currently available. Tablet formulations, for example, are often associated with illnesses and are not always accepted by patients, especially those with swallowing difficulties. Furthermore, they cannot be precisely portioned in the event of dose de-escalation. Orodispersible films have poor palatability and are difficult to portion into equal portions. A new formulation of sildenafil in oral suspension was recently introduced to the Italian market. The oral suspension, consisting of sprays of 12.5 mg of sildenafil at a time, is intended to meet patient needs in terms of rapid onset, efficacy, and therapeutic modulation.
The primary objective is to evaluate treatment satisfaction with sildenafil oral suspension in patients with mild-to-moderate ED who were previously taking orodispersible sildenafil.
The secondary objective is to evaluate the efficacy and side effects of therapy with sildenafil oral suspension compared to orodispersible sildenafil.
Primary endpoint: Change in the total satisfaction domain score after 3 months of treatment with sildenafil oral suspension 50 mg as needed compared to previous treatment with sildenafil orodispersible 50 mg as needed.
Secondary endpoints will be:
- Difference in efficacy between treatments assessed by the erectile function domain score;
- Differences in the frequency of side effects;
- Change in the PGI-I score;
- Change in the PAIRS-SF score.
- Conditions
- Erectile Dysfunction, Erectile Dysfunction (ED)
- Being tested
- Sildenafil Oral Suspension Compared to Orodispersible Tablets
- Keywords
- erectile dysfunction, sildenafil
- 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 Oral Suspension Compared to Orodispersible TabletsDrug
For the specific purpose of the study, only patients with mild-to-moderate ED (IIEF-EF 11-25) who had previously been treated with orodispersible sildenafil for 3 months will be considered.
In accordance with the European Guidelines for Sexual Medicine, after 3 months of treatment, completion of a new IIEF questionnaire is required to assess the effect of treatment on symptoms and the Global Impression of Improvement (PGI-I) scale, as well as the PAIRS-SF questionnaire.
Patients who, after at least 2 weeks of washout from orodispersible sildenafil, began treatment with sildenafil oral suspension for another 3 months will be selected and evaluated at the end of treatment with psychometric questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | group 1 Receives: Drug: Sildenafil Oral Suspension Compared to Orodispersible Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction measurement
Change in the total satisfaction domain score after 3 months of treatment with sildenafil oral suspension 50 mg as needed compared to previous treatment with sildenafil orodispersible 50 mg as needed
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jun 2026
- Primary completion31 Jul 2026
- Study completion31 Aug 2026
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Boeri, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676617
- Sponsor's protocol ID
- 6941
- Acronym
- SILOROS
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No