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

Laboratoires Genévrier

Status: Completed

Conditions: Erectile Dysfunction

Treatments: Drug: Xybilun

Study type: Observational

Funder types: Industry

Identifiers

NCT04114240

2017-A03204-49

Details and patient eligibility

About

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.

Full 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)

Enrollment: 105 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

105 participants in 4 patient groups

Xybilun: mild erectil dysfunction

Description:

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

Treatment:

Drug: Xybilun

Xybilun: moderate erectil dysfunction

Description:

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

Treatment:

Drug: Xybilun

Xybilun: severe erectil dysfunction

Description:

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

Treatment:

Drug: Xybilun

Xybilun switch

Description:

Substitution dose to dose of previous treatment by Xybilun whatever the severity of ED.

Treatment:

Drug: Xybilun