Status:
COMPLETED
French Study in Real Life Evaluating Xybilun
Lead Sponsor:
Laboratoires Genévrier
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18+ years
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.
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 inve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 23 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 26 2019
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04114240
Start Date
May 23 2018
End Date
April 26 2019
Last Update
October 4 2019
Active Locations (1)
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1
CHU Nîmes
Nantes, Haute-Bretagne, France, 44000