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

Ipsen Pharma GmBH0 个研究点目标入组 264 人开始时间: 2006年5月5日最近更新: 2020年10月13日

适应症

试验速览

暂无简介。

•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

•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 contraceptive pill, intra uterine device, diaphragm or barrier method such as barrier contraceptive.

发起方