Double-blind, cross-over, placebo-controlled pilot study to characterize the profile of those patients with traumatic spinal cord injury diagnosed by electrophysiological, urodynamic and clinical (ASIA group) assesment who may respond to vardenafil treatment. - LEMDE

QUIMICA FARMACEUTICA BAYER, S.A.0 个研究点目标入组 0 人开始时间: 2006年1月25日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•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

•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.

发起方

QUIMICA FARMACEUTICA BAYER, S.A.