French Study in Real Life Evaluating Xybilun

Erectile Dysfunction Clinical Trial

— XY-FILM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04114240
• Other study ID #: 2017-A03204-49
• Status: Completed
• Start date: May 23, 2018
• Est. completion date: April 26, 2019

Study information

• Verified date: October 2019
• Source: Laboratoires Genévrier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 26, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Xybilun
Erectil dysfunction, Viagra generic (sildénafil)

Locations

Country	Name	City	State
France	CHU Nîmes	Nantes	Haute-Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Genévrier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	safety	Adverse event : description of AE : open field, related or not to Xybilun, gravity scale (mild, moderate, severe, healththreatening)	1 month and 3 months