NCT00398580已完成2 期
A Phase II, 28-Day, Randomized, Parallel-Group, Open-Label Study Evaluating the Efficacy and Safety of Twice Daily Oral Doses of Testosterone (150-400mg) Co-administered With 0.25mg Dutasteride Compared With 400mg Testosterone Alone and 0.25mg Dutasteride Alone in the Treatment of Hypogonadism
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 7
- 主要终点
- Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine
研究概览
简要总结
The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the effect of 28-day repeat dosing of this combination with varying BID doses of testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well as a testosterone alone arm, on T and D levels in the blood. The rationale is to look for the effects of each compound on the other, and to look for any safety problems that may result when the 2 drugs are given together.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of primary or secondary hypogonadism.
- •Have very low testosterone levels on 2 separate days.
- •Have a BMI within range of 18.5-35kg/m
- •Have not taken dutasteride for one year, or finasteride for the past 3 months.
排除标准
- •Have had or have breast or prostate cancer, malabsorption syndrome, sleep apnea, psychiatric illness, polycythemia, or any other clinically significant current condition.
- •Are diabetic with an HbA1c >=
- •Are taking any androgens, such as testosterone, saw palmetto.
- •Are taking ritonavir, indinavir, itraconazole, ketoconazole, erythromycin, warfarin, digoxin, cholestyramine, or any dietary/herbal/vitamin supplements.
- •Would donate more than 500 ML of blood over a 2 month period.
- •Physician does not think it is a good idea for you to participate in the trial. - Are unwilling to abstain from alcohol during the study.
- •Have a positive urine drug screen test.
- •Plan to change your smoking habits during the course of the trial.
- •Have Hepatitis C, Hepatitis B, or HIV.
- •Have a lab or EKG abnormality.
- •High or low blood pressure.
- •Have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
结局指标
主要结局
Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine
时间窗: days 1 and 28
次要结局
- Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride(days 1 and 28.)
- Testosterone concentration .(on days 1 and 28)
- Anabolic & androgenic Pharmacodynamic biomarkers(pre- and post-dose)
研究者
研究点 (7)
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