Assessment of the effects of two different formulations of the same drug on the ability to obtain and maintain an erection which is adequate for satisfying sexual activity

Assessment of clinical efficacy of Sildenafil 75 mg orodispersable film vs Sildenafil 100 mg tablet in patients with erectile dysfunction - FAST

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001418-14-IT

Enrollment

118

Registered

2021-05-20

Start date

2019-07-11

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction MedDRA version: 20.0 Level: PT Classification code 10061461 Term: Erectile dysfunction System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: RABESTROM - " 75 MG FILM ORODISPERSIBILE " 8 FILM ORODISPERBILI IN BUSTINA AL/PET Product Name: Rabestrom Product Code: [na] Pharmaceutical Form: Sublingual film INN or Proposed INN: SILDE

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Male patients aged 18-72, with a diagnosis of Erectile Dysfunction based on DSM-V criteria - Diagnosis of erectile dysfunction in the last 12 months - Previous use of PDE-5 inhibitors (discontinued for at least 2 weeks) - Written consent to participate to the study for its whole duration Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 118 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 118

Exclusion criteria

Exclusion criteria: - Psychiatric illnesses - Abuse of alcohol and/or psychoactive drugs - Neuropathies, including peripheral neuropathies - Chronic use of psychiatric drugs - Male hypogonadism with total testosterone <12 nmol/l. - Treatment with nitrates or androgens. - Anatomical penile abnormalities which might cause erectile dysfunction. - Severe or moderate kidney or liver disease, recent stroke or myocardial infarction, heart failure - Previous use of PDE-5 inhibitors or topically administered proerectile drugs in the last 2 weeks - Hypersensitivity to the active substance or any of the excipients - Diagnosis of hypotension (blood pressure <90/50 mmHg) - Participation to a different clinical trial in the previous 30 days or 5 times the active substance’s half-life - Any biochemical alteration which, following the Investigator’s clinical judgement, would make the patient unsuitable for the present study - Known hereditary retinal degenerative disorders, such as retinitis pigmentosa

Design outcomes

Primary

Measure	Time frame
Main Objective: Changes in the erectile function domain of questionnaires for assessment of erectile function;Secondary Objective: Changes in scores of questionnaires aimed to assess male sexual functioning, psychosexual features and sexual intimacy;Primary end point(s): Scores of the erectile function domain in the International Index of Erectile Dysfunction (IIEF-15);Timepoint(s) of evaluation of this end point: at baseline, +3 months, + 6 months	—

Measure

Time frame

Main Objective: Changes in the erectile function domain of questionnaires for assessment of erectile function;Secondary Objective: Changes in scores of questionnaires aimed to assess male sexual functioning, psychosexual features and sexual intimacy;Primary end point(s): Scores of the erectile function domain in the International Index of Erectile Dysfunction (IIEF-15);Timepoint(s) of evaluation of this end point: at baseline, +3 months, + 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): Scores of the following questionnaires: Sexual Intimacy Rating Scale-SIRS, Orgasmometer, International Index of Erectile Dysfunction (IIEF-15), Premature Ejaculation Diagnostic Tool (PEDT), 90R-SCL90R; SIEDY; RQ e DAS.;Timepoint(s) of evaluation of this end point: at baseline, +3 months, + 6 months	—

Countries

Italy

Contacts

Public ContactDipartimento di Medicina Sperimenta

Sapienza Università di Roma

andrea.isidori@uniroma1.it06490530

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026