Erectile dysfunction (ED)
Conditions
Interventions
Trade Name: LEVITRA
Product Name: VARDENAFIL HIDROCLORIDE
Pharmaceutical Form: Buccal tablet
INN or Proposed INN: vardenafilo hidrocloruro
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
QUIMICA FARMACEUTICA BAYER, S.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men who have had erectile dysfunction for at least six months according to the National Institutes of Health (NIH) Consensus Conference December 7-9, 1992 2. History of Spinal Cord Injury of at least 6 months. 3. Stable heterosexual relationship 4. Written informed consent obtained. 5. Medical sexual history at inclusion should record at least four attempts at sexual intercourse on four separate days during the untreated screening period (according to the answer to the following question in the patient diary: “Was sexual activity initiated with the intention of intercourse?”). At least 50% of them during the untreated screening period must be unsuccessful, according to the following questions from the patient diary (at least one question should be answered “No”): “Were you able to achieve at least partial erection (some enlargement of the penis)?”(SEP1); “Were you able to insert your penis in the partner’s vagina?”(SEP2); ”Did your erection last long enough for you to have successful intercourse?” (SEP3). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the Investigator is likely to affect the patient’s ability to complete the study or precludes the patient’s participation in the study 2. Patients who have received any investigational drug (including placebo) within 30 days of Visit 1. 3. Use of any treatment for erectile dysfunction within 7 days of the selection visit or during the study, including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories 4. Patients unwilling to cease use of vacuum devices, intracavernosal injections, Viagraâ, Cialisâ or other therapy for erectile dysfunction during the study. 5. Unwillingness of the patient or his partner to make 4 attempts at sexual intercourse on four separate days during the untreated screening period. 6. Known hypersensitivity to any component of the investigational medication. 7. Patients who are illiterate or unable to understand the questionnaires or who are not prepared to complete the patient diary. 8. And those of de technical information of product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterise patients with ED secondary to a traumatic SCI lasting more than 6 months who respond to therapy with vardenafil in terms of electrophysiologic, urodynamic and clinical (ASIA scale) tests. Definition of responder: Patients with rigidity > 70% measured with RigiScan, during at least 5 minutes after withdrawing the vibrator ;Secondary Objective: - To study whether or not there is a difference in the time that an erection lasts with rigidity >70% between placebo and a 10 mg dose of vardenafil. - To study whether or not there is a difference in the time that an erection lasts with a rigidity >70% between a 10mg and a 20mg dose of vardenafil. - Assessment of the quality of the erection by the patient on a VAS scale between the best possible erection and the worst. - Tolerance of vardenafil in patients with ED due to a traumatic spinal cord injury. ;Primary end point(s): Characteristics of responders and non-responder with respect to the electrophysiologic tests (skin sympathetic response, bulbocavernosus reflex and somatosensory and pudendal evoked potential), urodynamic and clinical (ASIA scale) tests of each patient upon starting the trial. | — |
Countries
Spain
Outcome results
None listed