Clinical trial NCT04114240: French Study in Real Life Evaluating Xybilun
Official title: French Study in Real Life Evaluating Xybilun: Convenience and Erection Induction Related to a New Administration in Orodispersible Film
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Keywords: erectil dysfunction
sildenafil
xybilun
Lead sponsor: Laboratoires Genévrier
Sponsor class: INDUSTRY
First posted: 2019-10-03
Enrollment: 105
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Man suffering from all type of erectil dysfunction (light, moderate, severe).

Brief summary: Collecting Xybilun (Viagra's generic) efficacity, tolerance, convenience and patients/doctors satisfaction's data at different doses (50-75-100 mg), is the aim of the study.

Detailed description: Study design

Population Patients without prior treatment with a first Xybilun prescription Patients already treated for who the treatment is remplaced by Xybilun

Study perimeter 400 patients 50 investigators (sexologists, urologists)

Eligibility criteria: Inclusion Criteria:

* Age \> or equal 18 years
* Erectile dysfunction at V1 light (group 1), moderate (group 2), severe (group 3): IIEF-6 score between 6 and 25 (IIEF-6 questions 1-5 and question 15)
* More than 3 sexual intercourse
* First prescription of Xybilun (gr 1,2,3) or subtitution (gr 4)
* Information and non-opposition

Exclusion Criteria:

* Sildénafil hypersensitivity
* Treatment with nitrogen oxide or guanylate cyclase
* Patient with sexual intercourse prohibited
* NOIANA
* Alpha-blocker during past 3 months
* Norvir
* Participation in an other clinical trial
* Patient unable to read properly an information sheet
* Patient under guardianship/curatorship

Primary outcomes:
measure: Patients who has never been treated for ED (group 1,2,3) : responder patients rate at V3 (IIEF-6 : international index of erectil function)
timeFrame: 3 months
measure: Patients with treatment substitution (group 4): satisfaction of Xybilun vs previous treatment at V3 (Likert scale 5 points : 1-Not satisfied at all, 2-not very satisfied, 3-nor satisfied nor unsatisfied, 4- satisfied, 5-very satisfied)
timeFrame: 3 months
Secondary outcomes:
measure: Patients who has never been treated for ED (group 1,2,3) : responder patients at V2 Month 1 (IIEF-6)
timeFrame: 1 month
measure: Patients who has never been treated for ED (group 1,2,3) : overall satisfaction at 1 month and 3 month
timeFrame: 1 month and 3 months
measure: Patients who has never been treated for ED (group 1,2,3) : Patient Xybilun and investigator satisfaction at V2 month 1 and V3 month 3
timeFrame: 1 month and 3 months
measure: Patients who has never been treated for ED (group 1,2,3) : convenience at V2 month 1 and V3 month 3 (Likert scale)
timeFrame: 1 month and 3 months
measure: Patients who has never been treated for ED (group 1,2,3) : Partner satisfaction (Likert scale) at month 3
timeFrame: 3 months
measure: Patients with treatment substitution (group 4): International index of erectile function (IIEF) evolution (IIEF15)
timeFrame: 1 month and 3 months
measure: Patients with treatment substitution (group 4): satisfaction (patient/investigator) of previous treatment evaluated at V1 (Day 0) (Likert scale)
timeFrame: Day 0
measure: Patients with treatment substitution (group 4): satisfaction of Xybilun (patient/investigator) at V2 month 1 and V3 month 3 (Likert scale)
timeFrame: 1 month and 3 months
measure: Patients with treatment substitution (group 4): convenience previous treatment at V1 (day 0) (Likert scale)
timeFrame: Day 0
measure: Patients with treatment substitution (group 4): convenience Xybilun (patient) at V2 month 1 and V3 month 3 (Likert scale)
timeFrame: 1 month and 3 months
measure: Patients with treatment substitution (group 4): Partner satisfaction at V3 month 3 (Likert scale)
timeFrame: 3 months
measure: Patients with treatment substitution (group 4): reasons of treatment substitution
timeFrame: Day 0
measure: Patients with treatment substitution (group 4): efficacy of Xybilun comparing score IIEF-6 before/after treatment
timeFrame: 1 month and 3 months
measure: safety
timeFrame: 1 month and 3 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nîmes
state: Haute-Bretagne
Study officials:
affiliation: CHU Nîmes
name: DROUPY SD Stéphane, Urologist
role: PRINCIPAL_INVESTIGATOR
References: