Erectile DysfunctionXY-FILMNCT04114240
French Study in Real Life Evaluating Xybilun
An observational study of Erectile Dysfunction, run by Laboratoires Genévrier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Xybilun
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2018to 26 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Man suffering from all type of erectil dysfunction (light, moderate, severe).
Who may be able to join
- 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
Who cannot join
- Sildénafil hypersensitivity
- Treatment with nitrogen oxide or guanylate cyclase
- Patient with sexual intercourse prohibited
- NOIANA
- Alpha-blocker during past 3 months
- Norvir
Show all 9Show fewer
- Participation in an other clinical trial
- Patient unable to read properly an information sheet
- Patient under guardianship/curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Conditions
- Erectile Dysfunction
- Being tested
- Xybilun
- Keywords
- erectil dysfunction, sildenafil, xybilun
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XybilunDrug
Erectil dysfunction, Viagra generic (sildénafil)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Xybilun | |
| 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 Receives: Drug: Xybilun | |
| 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 Receives: Drug: Xybilun | |
| Xybilun switch | Substitution dose to dose of previous treatment by Xybilun whatever the severity of ED. Receives: Drug: Xybilun |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 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).
Measured: 3 months
Secondary outcomes (14)
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;
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)"
Measured: 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;
Measured: 1 month and 3 months
safety
Adverse event : description of AE : open field, related or not to Xybilun, gravity scale (mild, moderate, severe, healththreatening)
Measured: 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start23 May 2018
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Genévrier
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- DROUPY SD Stéphane, Urologist, Principal investigator, CHU Nîmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114240
- Sponsor's protocol ID
- 2017-A03204-49
- Acronym
- XY-FILM
- Status last verified
- Oct 2019
- First submitted
- 6 Sep 2018
- Last updated
- 4 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Study in Real Life Evaluating Xybilun: Convenience and Erection Induction Related to a New Administration in Orodispersible Film
- ClinicalTrials.gov ID
- NCT04114240
- Acronym / sponsor ID
- XY-FILM / 2017-A03204-49
- Conditions
- Erectile Dysfunction
- Keywords
- erectil dysfunction, sildenafil, xybilun
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Laboratoires GenévrierIndustry (pharma, biotech, devices)
- Study start
- 23 May 2018 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Xybilun: mild erectil dysfunction | – | Drug: XybilunPatient 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 |
| Xybilun: moderate erectil dysfunction | – | Drug: XybilunPatient 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 |
| Xybilun: severe erectil dysfunction | – | Drug: XybilunPatient who has never been treated for his ED (erectil dysfunction), with severe ED (score between 6 and 10) and begin treatment at 50 mg |
| Xybilun switch | – | Drug: XybilunSubstitution dose to dose of previous treatment by Xybilun whatever the severity of ED. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Man suffering from all type of erectil dysfunction (light, moderate, severe).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Sildénafil hypersensitivity
- Treatment with nitrogen oxide or guanylate cyclase
- Patient with sexual intercourse prohibited
- NOIANA
- Alpha-blocker during past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XybilunErectil dysfunction, Viagra generic (sildénafil) | Drug | Xybilun switch, Xybilun: mild erectil dysfunction, Xybilun: moderate erectil dysfunction, Xybilun: severe erectil dysfunction |
Primary outcome
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;
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).
14 secondary outcomes
Patients who has never been treated for ED (group 1,2,3) : responder patients at V2 Month 1 (IIEF-6)
Time frame: 1 month
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
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
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
Patients who has never been treated for ED (group 1,2,3) : Partner satisfaction (Likert scale) at month 3
Time frame: 3 months
Patients with treatment substitution (group 4): International index of erectile function (IIEF) evolution (IIEF15)
Time frame: 1 month and 3 months
Patients with treatment substitution (group 4): satisfaction (patient/investigator) of previous treatment evaluated at V1 (Day 0) (Likert scale)
Time frame: Day 0
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
Patients with treatment substitution (group 4): convenience previous treatment at V1 (day 0) (Likert scale)
Time frame: Day 0
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
Patients with treatment substitution (group 4): Partner satisfaction at V3 month 3 (Likert scale)
Time frame: 3 months
Patients with treatment substitution (group 4): reasons of treatment substitution
Time frame: Day 0
Patients with treatment substitution (group 4): efficacy of Xybilun comparing score IIEF-6 before/after treatment
Time frame: 1 month and 3 months
safety
Time frame: 1 month and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DROUPY SD Stéphane, Urologist principal investigator
CHU Nîmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by Laboratoires Genévrier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.