Satisfaction of Patients With Erectile Dysfunction With the Use of Sildenafil Oral Suspension Compared to Orodispersible Tablets

NCT07676617 | Active Not Recruiting FDA Drug

• 1 other identifier: 6941
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction; Erectile Dysfunction (ED)

Keywords

erectile dysfunction; sildenafil

Outcome Measures

Primary Outcomes (1)

• 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

  from enrollment to the end of treatment

Study Arms (1)

group 1

group 1

Drug: Sildenafil Oral Suspension Compared to Orodispersible Tablets

Interventions

Sildenafil Oral Suspension Compared to Orodispersible Tablets DRUG

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.

group 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Age 18-75
• Male
• Sexually active (at least 2 sexual encounters per week)
• IIEF-EF between 11 and 25 at baseline

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: June 1, 2026
• Primary Completion: July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

IT (1)