NCT00702650已完成3 期
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
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120
研究概览
简要总结
Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product- Testosterone MD-Lotion (cutaneous solution), and this study will evaluate the efficacy via pharmacokinetics of various doses of this product. The study will also assess safety of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects with a prior documented definitive diagnosis of hypogonadism as evidenced by previously documented:
- •Hypothalamic, pituitary or testicular disorder or age related idiopathic hypogonadism
- •Screening serum testosterone of less than or equal to 300 ng/dL (based on the average of two morning samples taken at least 30 minutes apart)
- •Were currently receiving treatment for hypogonadism in accordance with approved labelling, or in the Investigator's opinion are eligible to receive such treatment
- •Body Mass Index (BMI) < 35.0 kg/m^2
- •Haemoglobin levels at screening greater than or equal to 11.5 g/dL
- •Adequate venous access on left or right arm to allow collection of a number of samples by venipuncture
- •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
排除标准
- •Current use of long acting testosterone injectables such as Nebido®
- •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
- •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 subject
- •Chronic skin disorder (e.g. eczema, psoriasis) likely to interfere with transdermal drug absorption
- •Men with suspected reversible hypogonadism
- •Any man in whom testosterone therapy was contraindicated, which included 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 International Prostate Symptom Scores (IPSS) scores of greater than or equal to 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
- •Haematocrit of > 51
- •Untreated moderate to severe depression
- •Men with clinically significant prostate exam (such as irregularities or nodules palpated) or clinically significant elevated serum Prostate Specific Antigen (PSA) levels (>4 ng/mL), or age adjusted reference range of PSA values
- •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)
- •Men taking concomitant medications (prescribed, over-the-counter or complementary) that would affect sex hormone binding globulin (SHBG) or testosterone concentrations or metabolism, warfarin, insulin, opiates, Gonadotropin-releasing hormone (GnRH), 5 alpha reductase inhibitors, propanolol, oxyphenbutazone, corticosteroids (except for physiological replacement doses), estradiol
- •Men involved in sport in which there is screening for anabolic steroids
- •Men with uncontrolled diabetes (haemoglobin A1c [HbA1c] greater than or equal to 10%)
- •Men currently taking any investigational product, or have received an investigational product within 28 days prior to screening or 5 half-lives
- •Any contraindication to blood sampling
- •Subjects intending to have any surgical procedure during the course of the trial
- •Subjects with a partner of child bearing potential who are not willing to use adequate contraception for the duration of the trial
- •Subjects whose partners are pregnant
研究组 & 干预措施
Testosterone MD-Lotion
Experimental
Participants received Testosterone Metered Dose (MD)-Lotion for 120 days. Participants started by receiving 3.0 mL (60 mg) of 2% Testosterone MD-Lotion, and based upon restoration to eugonadal levels, may have had their dose of testosterone adjusted upwards or downwards on Days 45 and 90.
Doses could be titrated to one of the following:
1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied daily by 1 dose to the axilla (1.5 mL to one axilla).
3.0 mL (60 mg) of 2% Testosterone MD-Lotion applied daily by 2 doses to the axilla (1.5 mL to each axilla).
4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied daily by 3 doses to the axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
6.0 mL (120 mg) of 2% Testosterone MD-Lotion applied daily by 4 doses to the axilla (2 x 1.5 mL to each axilla).
干预措施: Testosterone MD-Lotion (Drug)
结局指标
主要结局
Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120
时间窗: Day 120
Cavg(0-24) is the average serum concentration calculated over the 24 hour period on Day 120. Calculated as the AUC(0-24) divided by 24 hours. Normal range for Total Testosterone was defined as 300 - 1050 nanograms per deciliter (ng/dL).
次要结局
- Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL(Day 120)
- Percentage of Participants With Cmax Between 1800 and 2500 ng/dL(Day 120)
- Percentage of Participants With Cmax >2500 ng/dL(Day 120)
- Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL(Day 120)
- Change From Baseline to Endpoint in Psychosexual Daily Questionnaire(Baseline, Day 120)
- Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36)(Baseline, Day 120)
- Change From Baseline to Endpoint in Fasting Insulin(Baseline, up to Day 120)
- Change From Baseline to Endpoint in Fasting Glucose(Baseline, up to Day 120)
- Change From Baseline to Endpoint in Prostate Specific Antigen (PSA)(Baseline, Day 120)
- Change From Baseline to Endpoint in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)(Baseline, up to Day 120)
- Change From Baseline to Endpoint in Estradiol(Baseline, up to Day 120)
- Change From Baseline to Endpoint in Haemoglobin(Baseline, up to Day 120)
- Change From Baseline to Endpoint in Haematocrit(Baseline, up to Day 120)
- Change From Baseline to Endpoint in Draize Score(Baseline, Day 120)
研究者
研究点 (1)
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