EUCTR2005-005060-92-BE进行中（未招募）1 期
Phase IIIB, Double Blind, Placebo Controlled, International, Multicenter, Parallel Group Study, to Assess the Efficacy and Safety of Testim Gel in Combination with a Phosphodiesterase V Inhibitor (Tadalafil), in Male Patients with Low or <Borderline> Baseline Serum Testosterone Levels and Erectile Dysfunction - TESTIMED
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 264
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
- 性别
- Male
入选标准
- •1. Have ED defined as a score < 26 in the erectile function module of the IIEF scale
- •2. Have a score <3 (sometimes) to both question 3 (successful penetration) and question 4 (successful maintenance of erection after penetration) of the IIEF scale
- •3. Have a serum total testosterone level <12 nmol/L (346 ng/dL) assayed on two samples drawn between 7 and 10 am on two separate days: -one at V1 visit performed by central lab; -one 10 to 14 days before V2 performed by central lab
- •4. Have not been treated with testosterone since the selection visit
- •5. Have not been treated with PDE5 inhibitors since the selection visit
- •6. Have kept the same female partner since the selection visit
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients having any contra-indication to tadalafil treatment: stroke within last 6 months, myocardial infarction within the last 90 days, unstable angina or angina occurring during sexual intercourse, New York Heart Association Class 2 or greater heart failure in the last 6 months, uncontrolled arrhythmias, hypotension (<90/50 mm Hg) or uncontrolled hypertension (>170/100 mm Hg), clinically significant renal (creatinine clearance <30 mL/min) or hepatic insufficiency (Child-Pugh Class C), patients receiving organic nitrates
- •2. Patients having any contra-indication to testosterone therapy: breast carcinoma, prostate carcinoma, suspected prostate carcinoma (PSA > 4 ng/mL), abnormal findings at the Digital Rectal Examination (DRE)
- •3. Patients with known hypersensitivity to tadalafil, testosterone or other drug with a similar chemical structure or any of the excipients
- •4. Patients having drug induced ED
- •5. Patients having poorly controlled diabetes defined by Glycosylated Haemoglobin (HbA1c)>10%
- •6. Patients having history of non-arteritic anterior ischaemic optic neuropathy
- •7. Patients having received any unlicensed drug within the previous 30 days
- •8. Patients requiring treatment during the study with drugs that are not permitted by the study protocol
- •9. Patients trying to have a baby or planning to in the study period. Adequate contraception such as contracetive pill, intra uterine device, diaphragm or barrier method such as barrier contraceptive
研究者
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