EUCTR2007-001058-16-FR进行中（未招募）1 期
A PHASE II DOUBLE-BLIND VEHICLE-CONTROLLED CROSSOVER SINGLE DOSE (400 µG) V0147 GEL EFFECT AND TOLERANCE STUDY IN SPINAL CORD INJURED PATIENTS WITH ERECTILE DYSFUNCTIO
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •·Male,18-40 years of age,
- •Body mass index (BMI) between 18 and 32,
- •With erectile dysfunction (ED) resulting from spinal cord injury,
- •Spinal cord injury (SCI) at least 6 months before pre-selection visit,
- •With normal erectile function before SCI,
- •Mild to moderate ED with an Erectile Function domain score of the International Index of Erectile Function (IIEF) = 17 and = 21,
- •Patient accepting not to use any product in the same indication during the study period,
- •Patient accepting to participate to the study and to give a written informed consent,
- •Registered with a social security or health insurance system
- •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
排除标准
- •Criteria related to pathologies:
- •Clinically significant anatomical abnormalities such as phimosis,
- •La Peyronie’s disease, penile curvature, penile nodules or fibrosis, history of priapism,
- •Penile implant,
- •Chronic medical illness (hypertension, diabetes mellitus, renal or hepatic dysfunction, atherosclerosis, cardiovascular risk factors including hyperlipidemia),
- •Criteria related to treatments:
- •Intake of any drug inducing erectile response within the week preceding the pre-selection visit (PDE5 inhibitors, alprostadil, papaverine), or use of vacuum pumps,
- •Any androgen therapy,
- •Treatment with any medication that may cause erectile dysfunction,
- •Non-responders to intracavernous injections of PGE1 whatever the dose or to PDE5 inhibitors.
- •History of hypersensitivity (abnormal drug reaction or idiosyncrasy or asthma) to alprostadil or to at least one ingredient of the test product.
- •Criteria related to the population:
- •Patient whose partner is pregnant or may become pregnant during the study.
- •Patient who is in the 1-month exclusion period of a previous study or participating to another clinical trial during this study,
- •Patient who has a history of major medical/psychiatric illness or surgery which, in the judgment of the investigator, may interfere with study medication metabolism and/or study implementation and/or study parameter assessment,
- •Patient who has forfeited his freedom by administrative or legal award, or who is under guardianship, or who has been admitted to a sanitary or social institution, or who is in an emergency situation.
研究者
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