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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04114240
Recruitment Status : Completed
First Posted : October 3, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Laboratoires Genévrier

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.

Condition or disease Intervention/treatment
Erectile Dysfunction 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)

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Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: French Study in Real Life Evaluating Xybilun: Convenience and Erection Induction Related to a New Administration in Orodispersible Film
Actual Study Start Date : May 23, 2018
Actual Primary Completion Date : April 26, 2019
Actual Study Completion Date : April 26, 2019

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)




Primary Outcome Measures :
  1. Patients who has never been treated for ED (group 1,2,3) : responder patients rate at V3 (IIEF-6 : international index of erectil function) [ Time Frame: 3 months ]
    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;

  2. 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) [ Time Frame: 3 months ]
    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).


Secondary Outcome Measures :
  1. Patients who has never been treated for ED (group 1,2,3) : responder patients at V2 Month 1 (IIEF-6) [ Time Frame: 1 month ]
    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;

  2. Patients who has never been treated for ED (group 1,2,3) : overall satisfaction at 1 month and 3 month [ Time Frame: 1 month and 3 months ]
    GAQ Global Assessment Questionnaire : 1 question "does the treatment has ameliorate your erection" Y/N

  3. 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 [ Time Frame: 1 month and 3 months ]
    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)

  4. Patients who has never been treated for ED (group 1,2,3) : convenience at V2 month 1 and V3 month 3 (Likert scale) [ Time Frame: 1 month and 3 months ]
    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)

  5. Patients who has never been treated for ED (group 1,2,3) : Partner satisfaction (Likert scale) at month 3 [ Time Frame: 3 months ]
    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)

  6. Patients with treatment substitution (group 4): International index of erectile function (IIEF) evolution (IIEF15) [ Time Frame: 1 month and 3 months ]
    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)

  7. Patients with treatment substitution (group 4): satisfaction (patient/investigator) of previous treatment evaluated at V1 (Day 0) (Likert scale) [ Time Frame: Day 0 ]
    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)

  8. Patients with treatment substitution (group 4): satisfaction of Xybilun (patient/investigator) at V2 month 1 and V3 month 3 (Likert scale) [ Time Frame: 1 month and 3 months ]
    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)

  9. Patients with treatment substitution (group 4): convenience previous treatment at V1 (day 0) (Likert scale) [ Time Frame: Day 0 ]
    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)

  10. Patients with treatment substitution (group 4): convenience Xybilun (patient) at V2 month 1 and V3 month 3 (Likert scale) [ Time Frame: 1 month and 3 months ]
    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)

  11. Patients with treatment substitution (group 4): Partner satisfaction at V3 month 3 (Likert scale) [ Time Frame: 3 months ]
    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)

  12. Patients with treatment substitution (group 4): reasons of treatment substitution [ Time Frame: Day 0 ]
    1 question : "reason of substitution : lack of efficacy, adverse event, bad taste, difficulty of taking, price elevated, ED healing, other (precise)"

  13. Patients with treatment substitution (group 4): efficacy of Xybilun comparing score IIEF-6 before/after treatment [ Time Frame: 1 month and 3 months ]
    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;

  14. safety [ Time Frame: 1 month and 3 months ]
    Adverse event : description of AE : open field, related or not to Xybilun, gravity scale (mild, moderate, severe, healththreatening)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Man suffering from all type of erectil dysfunction (light, moderate, severe).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114240


Locations
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France
CHU Nîmes
Nantes, Haute-Bretagne, France, 44000
Sponsors and Collaborators
Laboratoires Genévrier
Investigators
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Principal Investigator: DROUPY SD Stéphane, Urologist CHU Nîmes

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Responsible Party: Laboratoires Genévrier
ClinicalTrials.gov Identifier: NCT04114240    
Other Study ID Numbers: 2017-A03204-49
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laboratoires Genévrier:
erectil dysfunction
sildenafil
xybilun
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents