Erectile Dysfunction
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: equ
Sponsors
Unidad de Neuroinmunología
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.Stable multiple sclerosis. 3.Stable heterosexual relationship. 4.Written informed consent obtained. 5.The patient must make 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?”). 6. At least 50% of attempts at sexual intercourse 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)?”; “Were you able to insert your penis in the partner’s vagina?”; ”Did your erection last long enough for you to have successful intercourse?”. 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) 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. Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie’s disease) which, in the Investigator’s opinion, would significantly impair erectile function. 3. Primary hypoactive sexual desire. 4.History of surgical prostatectomy (excluding TURP). 5. Retinitis pigmentosa. 6. Unstable angina pectoris. 7. Autonomic dysreflexia. ... Those specified on the tachnical manual. 20. Multiple sclerosis with outbreaks in the last 3 months and/or an increase on scale EDSS of 1 in the last 6 months. - Patients unwilling to cease use of vacuum devices, intracavernosal injections, - Viagra, Cialis or other therapy for erectile dysfunction during the study. - Unwillingness of the patient or his partner to make 4 attempts at sexual intercourse on four separate days during the untreated screening period. -Known hypersensitivity to any component of the investigational medication. - Patients who are illiterate or unable to understand the questionnaires or who are not prepared to complete the patient diary. - History within the last 6 months of severe migraine headaches occurring once monthly or more frequently. - Subjects unwilling to refrain from consuming grapefruit juice or products containing grapefruit juice with study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy placebo controlled of flexible doses of vardenafil on the erectile function (punctuation obtained on the erectile function domain of the IIEF questionnaire) in patients affected of multiple sclerosis and erectile dysfunction.;Secondary Objective: - Effect of the influence of vardenfil on intercourse satisfaction. - Patient satisfaction with treatment. - Tolerability of vardenafil on patients suffering from MS.;Primary end point(s): Punctuation obtained on the erectile function domain of the International Index of Erectile Function questionnaire (Questions 1-5 and 15 of the IIEF). | — |
Countries
Spain
Outcome results
None listed