French Study in Real Life Evaluating Xybilun (XY-FILM)

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

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: Xybilun

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)

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• France
  • Haute-Bretagne
    • Nantes, Haute-Bretagne, France, 44000
      • Chu Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Man suffering from all type of erectil dysfunction (light, moderate, severe).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Xybilun: mild erectil dysfunction; 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; Erectil dysfunction, Viagra generic (sildénafil)
Xybilun: moderate erectil dysfunction; 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; Erectil dysfunction, Viagra generic (sildénafil)
Xybilun: severe erectil dysfunction; 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; Erectil dysfunction, Viagra generic (sildénafil)
Xybilun switch; Substitution dose to dose of previous treatment by Xybilun whatever the severity of ED.	Drug: Xybilun; Erectil dysfunction, Viagra generic (sildénafil)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laboratoires Genévrier
• Investigators: Principal Investigator: DROUPY SD Stéphane, Urologist, Chu Nimes

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2018
• Primary Completion (Actual): April 26, 2019
• Study Completion (Actual): April 26, 2019

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: sildenafil; erectil dysfunction; xybilun
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: 2017-A03204-49

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No