French Study in Real Life Evaluating Xybilun

Study Overview
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Brief Summary
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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
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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)

Official Title
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French Study in Real Life Evaluating Xybilun: Convenience and Erection Induction Related to a New Administration in Orodispersible Film

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: Xybilun


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Xybilun: mild erectil dysfunction<br>Patient who has never been treated for his ED (erectil dysfunction), with mild ED (score IIEF-6 between 22 and 25) and begin treatment at 50 mg | Drug: Xybilun<br>* Erectil dysfunction, Viagra generic (sildénafil)<br>|
| Xybilun: moderate erectil dysfunction<br>Patient who has never been treated for his ED (erectil dysfunction), with moderate ED (score IIEF-6 between 11 and 21) and begin treatment at 50 mg | Drug: Xybilun<br>* Erectil dysfunction, Viagra generic (sildénafil)<br>|
| Xybilun: severe erectil dysfunction<br>Patient who has never been treated for his ED (erectil dysfunction), with severe ED (score between 6 and 10) and begin treatment at 50 mg | Drug: Xybilun<br>* Erectil dysfunction, Viagra generic (sildénafil)<br>|
| Xybilun switch<br>Substitution dose to dose of previous treatment by Xybilun whatever the severity of ED. | Drug: Xybilun<br>* Erectil dysfunction, Viagra generic (sildénafil)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients who has never been treated for ED (group 1,2,3) : responder patients rate at V3 (IIEF-6 : international index of erectil function) | Group 1: patient good responder if there is an increase of at least 2 points regarding score of IIEF-6; Group 2: patient good responder if there is an increase of at least 5 points regarding score of IIEF-6; Group 3: patient good responder if there is an increase of at least 7 points regarding score of IIEF-6; | 3 months | 
| 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) | Likert scale in 5 point evaluated at V3: Are you more satisfied regarding you previous treatment then your current treatment? Patient improved if his answer is satisfied (score 4) or very satisfied (score 5). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients who has never been treated for ED (group 1,2,3) : responder patients at V2 Month 1 (IIEF-6) | score IIEF-6 (international index erectif function) score frome 0 to 30 : 22-25 ED mild, 11-21 ED moderate, 6-10 ED severe Group 1: patient good responder if there is an increase of at least 2 points regarding score of IIEF-6; Group 2: patient good responder if there is an increase of at least 5 points regarding score of IIEF-6; Group 3: patient good responder if there is an increase of at least 7 points regarding score of IIEF-6; | 1 month | 
| Patients who has never been treated for ED (group 1,2,3) : overall satisfaction at 1 month and 3 month | GAQ Global Assessment Questionnaire : 1 question does the treatment has ameliorate your erection Y/N | 1 month and 3 months | 
| 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 | Likert scale (5 points) : 1 question : are you satisfied of Xybilun? (Likert scale 5 points : 1-Not satisfied at all, 2-not very satisfied, 3-nor satisfied nor unsatisfied, 4- satisfied, 5-very satisfied) | 1 month and 3 months | 
| Patients who has never been treated for ED (group 1,2,3) : convenience at V2 month 1 and V3 month 3 (Likert scale) | Likert scale (5 points) : 1 question How convenient Xybilun is ?) (Likert scale 5 points : 1-Not convenient at all, 2-not very convenient, 3-nor convenient nor unconvenient, 4- convenient, 5-very convenient) | 1 month and 3 months | 
| Patients who has never been treated for ED (group 1,2,3) : Partner satisfaction (Likert scale) at month 3 | Likert scale (5 points): (optional data) 1 question : are you satisfied of Xybilun? (Likert scale 5 points : 1-Not satisfied at all, 2-not very satisfied, 3-nor satisfied nor unsatisfied, 4- satisfied, 5-very satisfied) | 3 months | 
| Patients with treatment substitution (group 4): International index of erectile function (IIEF) evolution (IIEF15) | IIEF15 international index of erectile function (15 questions scored from 0 to 5) ; score from 0 to 75 to evaluate globale erectil dysfunction (not used for classify the disfunction only to see the score evolution in the time) | 1 month and 3 months | 
| Patients with treatment substitution (group 4): satisfaction (patient/investigator) of previous treatment evaluated at V1 (Day 0) (Likert scale) | Likert scale (5 points) : Are you more satisfied regarding you previous treatment then your current treatment? scale 5 points : 1-Not satisfied at all, 2-not very satisfied, 3-nor satisfied nor unsatisfied, 4- satisfied, 5-very satisfied) | Day 0 | 
| Patients with treatment substitution (group 4): satisfaction of Xybilun (patient/investigator) at V2 month 1 and V3 month 3 (Likert scale) | Likert scale (5 points) : 1 question : are you satisfied of Xybilun? (Likert scale 5 points : 1-Not satisfied at all, 2-not very satisfied, 3-nor satisfied nor unsatisfied, 4- satisfied, 5-very satisfied) | 1 month and 3 months | 
| Patients with treatment substitution (group 4): convenience previous treatment at V1 (day 0) (Likert scale) | Likert scale (5 points) 1 question How convenient you previous treatment was ?) (Likert scale 5 points : 1-Not convenient at all, 2-not very convenient, 3-nor convenient nor unconvenient, 4- convenient, 5-very convenient) | Day 0 | 
| Patients with treatment substitution (group 4): convenience Xybilun (patient) at V2 month 1 and V3 month 3 (Likert scale) | Likert scale (5 points) 1 question How convenient Xybilun is ?) (Likert scale 5 points : 1-Not convenient at all, 2-not very convenient, 3-nor convenient nor unconvenient, 4- convenient, 5-very convenient) | 1 month and 3 months | 
| Patients with treatment substitution (group 4): Partner satisfaction at V3 month 3 (Likert scale) | ikert scale (5 points): (optional data) 1 question : are you satisfied of Xybilun? (Likert scale 5 points : 1-Not satisfied at all, 2-not very satisfied, 3-nor satisfied nor unsatisfied, 4- satisfied, 5-very satisfied) | 3 months | 
| Patients with treatment substitution (group 4): reasons of treatment substitution | 1 question : reason of substitution : lack of efficacy, adverse event, bad taste, difficulty of taking, price elevated, ED healing, other (precise) | Day 0 | 
| Patients with treatment substitution (group 4): efficacy of Xybilun comparing score IIEF-6 before/after treatment | score IIEF-6 (international index erectif function) score frome 0 to 30 : 22-25 ED mild, 11-21 ED moderate, 6-10 ED severe ED mild: responder if there is an increase of at least 2 points regarding score of IIEF-6; ED moderate: responder if there is an increase of at least 5 points regarding score of IIEF-6; ED severe: responder if there is an increase of at least 7 points regarding score of IIEF-6; | 1 month and 3 months | 
| safety | Adverse event : description of AE : open field, related or not to Xybilun, gravity scale (mild, moderate, severe, healththreatening) | 1 month and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erectil dysfunction, sildenafil, xybilun