EUCTR2005-005060-92-IT进行中（未招募）不适用
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
相关药物
试验速览
- 阶段
- 不适用
- 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 8804; 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 the 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 170/100mmHg - 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 Prostate Specific Antigen 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 see Section 8.7 9. Patients trying to have a baby or planning to in the study period. Requirement for using of adequate contraception such as contraceptive pill, intra uterine device, diaphragm or barrier method such as barrier contraceptive 10. Patients having history of, or known current, problems with alcohol abuse 11. Any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude, unless the disease under study is such that the subject presents with such symptoms and the consent of a legal guardian or carer must be sought providing the latter is permitted by the local legislation 12. Any other condition that, in the opinion of the investigator, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objective s of the study.
研究者
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