Erectile Dysfunction Clinical Trial
— XY-FILMOfficial title:
French Study in Real Life Evaluating Xybilun: Convenience and Erection Induction Related to a New Administration in Orodispersible Film
NCT number | NCT04114240 |
Other study ID # | 2017-A03204-49 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 23, 2018 |
Est. completion date | April 26, 2019 |
Verified date | October 2019 |
Source | Laboratoires Genévrier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Nîmes | Nantes | Haute-Bretagne |
Lead Sponsor | Collaborator |
---|---|
Laboratoires Genévrier |
France,
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 |
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