Erectile dysfunction MedDRA version: 20.0 Level: LLT Classification code 10020381 Term: Hormonal imbalance System Organ Class: 100000004848
Conditions
Interventions
Trade Name: XEOMIN
Product Name: XEOMIN
Pharmaceutical Form: Powder for solution for injection
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the plac
Sponsors
None listed
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - For the open-label run-in phase (4 week duration): Subjects have to fulfill all of the following criteria before being included in the open-label run-in phase: 1. Written informed consent signed before any study-specific procedure 2. History of ED for at least 6 months prior to screening, defined as “the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse”. The diagnosis of ED had to be confirmed by a physician 3. Stable, heterosexual relationship for at least 6 months prior to screening 4. Aged =18 to = 80 years at visit 1 the first screening examination 5. Highly motivated to obtain treatment for ED according to physician judgment 6. History of previous use of at least 1 marketed PDE5-I and insufficient therapeutic efficacy despite use of the highest approved dose 7. Ability to understand and follow study-related instructions - For the double-blind treatment phase (3 month duration): Subjects have to fulfill all of the following criteria before being included in the double-blind treatment phase: 1. At least 4 attempts at sexual intercourse on 4 separate days during the open-label run-in phase with use of 100 mg sildenafil approximately 1 hour before attempting intercourse (according to the answer to the following question in the Subject Diary: “Was sexual activity initiated with the intention of intercourse?”) 2. IIEF-EF score =65 years) yes F.1.3.1 Number of subjects for this age range 126
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to the active substance (Clostridium Botulinum neurotoxin type A) or to any of the excipients (Human albumin, sucrose) Any cardiovascular condition, incl. unstable angina pectoris that would have precluded sexual activity 2. History of myocardial infarction, stroke within 6 months prior to screening 3. Presence of penile anatomical abnormalities such as penile fibrosis or Lapeyronie’s disease which, in the investigator’s opinion, would have significantly impaired sexual performance4. Concomitant use of nitrates / nitric oxide donors 4. Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome) 5. Prior injection of botulinum toxin A in any site for any indication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of intracavernosal Clostridium Botulinum neurotoxin type A(Xeomin®) 100U as add-on therapy to sildenafil 100 mg on demand in men with ED and insufficient response to standard oral therapy with sildenafil 100 mg on demand during the 4-week open-label run-in-phase. ;Secondary Objective: The secondary objectives are to further describe the efficacy and safety of Clostridium Botulinum neurotoxin type A(Xeomin®) 100U IC as add-on therapy to sildenafil 100 mg on demand.;Primary end point(s): The primary efficacy endpoint is the change in the erectile function between baseline and month 3, measured by the International Index of Erectile Function – Erectile Function subscale (IIEF-EF). The International Index of Erectile Function (IIEF) is a 15-item self-report instrument assessing male sexual function. The Erectile Function (EF) domain score of the IIEF, comprised of items 1 to 5 and 15 from the IIEF, is used in this study.;Timepoint(s) of evaluation of this end point: 1 month; 3 month; 6month and 9 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): i. The Sexual Encounter Profile (SEP). The SEP is a log diary with 5 questions answered after each sexual intercourse attempt, providing information as to whether the erection was hard enough to penetrate (SEP 2), or whether it was maintained for completion (SEP 3) or a satisfactory sexual experience (SEP 4). ii. The Erection Hardness Score (EHS). The EHS is a single-item Likert scale. The tool asks men to consider the question ‘How would you rate the hardness of your erection?’ and select one of the options below: 0 – Penis does not enlarge 1 – Penis is larger, but not hard 2 – Penis is hard, but not hard enough for penetration 3 – Penis is hard enough for penetration, but not completely hard 4 – Penis is completely hard and fully rigid iii. Global Assessment Question (GAQ1): “Has the treatment you have been taking over the past 4 weeks improved your erections? (Please compare your current erections after treatment with your erections before your participation in this study)”: yes or no and if necessary GAQ2 ‘If yes, has the treatment improved your ability to engage in sexual activity?’ iv. Persistence of efficacy at 6 and 9 month post- Xeomin® 100U IC using the same tools: IIEF-EF, SEP, EHS, GAQ For safety: Nature, number and severity of adverse events | — |
Countries
France
Outcome results
None listed