EUCTR2008-001060-36-SE进行中（未招募）不适用
A Phase III open-label titration trial to evaluate the effectiveness and safety of different doses of a dermal application of Testosterone MD-Lotion® (cutaneous solution) in hypogonadal men
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •Patients who meet all of the following criteria may be entered into the trial:
- •1.Male subjects greater than 18 years of age with a prior documented definitive diagnosis of hypoandrogenism as evidenced by previously documented:
- •Hypothalamic, pituitary or testicular disorder or age related idiopathic hypogonadism,
- •Screening serum testosterone of =300ng/dL (based on the average of two morning samples taken at least 30 minutes apart),
- •2.Are currently receiving treatment (buccal, oral, transdermal or intramuscular androgen replacement) for hypoandrogenism in accordance with approved labeling, or in the Investigator’s opinion are eligible to receive such treatment,
- •3.Body Mass Index (BMI) <35.0kg/m2,
- •4.Haemoglobin levels at screening = 11.5g/dL,
- •5.Adequate venous access on left or right arm to allow collection of a number of samples by venipuncture,
- •6.Ability to communicate with the trial staff, understand the Trial Information Sheet and sign the Written Informed Consent Forms; willing to follow the Protocol requirements and comply with Protocol restrictions and procedures.
- •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
- •Patients who meet any of the following criteria will not be eligible for participation in this trial:
- •1.Current use of long acting testosterone injectables such as Nebido®,
- •2.Any significant history of allergy and/or sensitivity to the drug products or their excipients, including any history of sensitivity to testosterone and/or sunscreens,
- •3.Any clinically significant chronic illness or finding on screening physical exam and/or laboratory testing that makes it undesirable for the Investigator to enrol the trial subject in the trial and/or that in the Investigator’s opinion, would interfere with the trial objectives or safety of the patient,
- •4.Chronic skin disorder (eg. eczema, psoriasis) likely to interfere with transdermal drug absorption,
- •5.Men with suspected reversible hypoandrogenism (i.e. due to medications, stress),
- •6.Any man in whom testosterone therapy is contraindicated, which includes those with:
- •-Known or suspected carcinoma (or history of carcinoma) of the prostate or clinically significant symptoms of benign prostatic hyperplasia and/or clinically significant symptoms of lower urinary obstruction and IPSS scores of =19,
- •-Known or suspected carcinoma (or history of carcinoma) of the breast,
- •-Severe liver disease (i.e. cirrhosis, hepatitis or liver tumours or liver function tests >2 times the upper limit of the normal range values),
- •-Active deep vein thrombosis, thromboembolic disorders or a documented history of these conditions,
- •-Current significant cerebrovascular or coronary artery disease,
- •-Untreated sleep apnoea,
- •-Hematocrit of >51,
- •-Untreated moderate to severe depression,
- •7.Men with clinically significant prostate exam (such as irregularities or nodules palpated) or clinically significant elevated serum Prostate Specific Antigen (PSA) levels (>4ng/mL), or age adjusted reference range of PSA values,
- •8.Current or history of drug or alcohol abuse (more than 4 standard drinks per day and/or abnormal liver function tests > 2 times the upper limit of the normal range values),
- •9.Men taking concomitant medications (prescribed, over-the-counter or complementary) that would affect SHBG or testosterone concentrations or metabolism, warfarin, insulin, opiates, GnRH, 5 alpha reductase inhibitors, propanolol, oxyphenbutazone, corticosteroids (except for physiological replacement doses), estradiol
- •10.Men involved in sport in which there is screening for anabolic steroids,
- •11.Men with uncontrolled diabetes (HbA1c=10%),
- •12.Men currently taking any investigational product, or have received an investigational product within 28 days prior to screening or 5 half-lives (whichever is the longer),
- •13.Any contraindication to blood sampling,
- •14.Subjects intending to have any surgical procedure during the course of the trial,
- •15.Subjects with a partner of child bearing potential who are not willing to use adequate contraception for the duration of the trial,
- •16.Subjects whose partners are pregnant.
研究者
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