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Completed

NCT Number: NCT04114240

French Study in Real Life Evaluating Xybilun

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.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

CHU Nîmes

Nantes, Haute-Bretagne, 44000, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xybilun

Drug

Erectil dysfunction, Viagra generic (sildénafil)

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Laboratoires Genévrier

Industry

Registry information

Official study title

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

Acronym: XY-FILM

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2019
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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