Sildenafil Oral Suspension Compared to Orodispersible Tablets
Sildenafil Oral Suspension Compared to Orodispersible Tablets: 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 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.
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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Age 18-75
* Male
* Sexually active (at least 2 sexual encounters per week)
* IIEF-EF between 11 and 25 at baseline
Exclusion Criteria:
* 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
* 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.
Primary outcome measure(s)
Satisfaction measurement — from enrollment to the end of treatment 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
Trial sites (1)
Facility
City
Region
Status
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
Italy
More Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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