NCT01786473Unknown3 期
A Multi-center, Double Blind, Randomized, Placebo Controlled Study of Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Percentage of patients with morning serum Total Testosterone concentration within the physiological range (300 - 1000 ng/dL or 10.4 - 34.7 nmol/L) after 3 months of Testogel treatment compared to placebo-treatment
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Testogel® 50mg/5g gel administered once daily (QD, morning dosing) compared to placebo administered once daily (QD, morning dosing), for 3 months, in hypogonadal men with testosterone deficiency being confirmed by clinical features and biochemical tests. For men with hypogonadism, treatment aims to restore testosterone levels to normal physiological range.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male ages 18-68 years diagnosed as having testosterone deficiency with clinical symptoms
- •A morning (8:00-10:00) serum Total Testosterone concentration of ≤ 300 ng/dL, confirmed by a second measurement of morning serum Total Testosterone concentration ≤ 300 ng/dL (samples to be taken 1 - 3 weeks apart)
排除标准
- •Abnormal prostate as evidenced by prostatic symptoms, prostatic masses or induration on rectal examination, or elevated levels of prostate specific antigen (PSA > 4ng/ml) or a maximum urine flow rate of less than 12 ml/sec(of a urine volume greater than 150ml) (and/or an International Prostate Symptom Score IPSS score >19)
- •Hematocrit > 50%
- •Major psychiatric illness
- •Unable to understand the protocol or to give informed consent
- •Use of paroxetine and clomipramine
- •Active alcoholism
- •History of drug abuse within the past five years;
- •Use of drugs that might interfere with the results of the study (e.g., antiandrogen, estrogens or P 450 enzyme inducers, barbiturates);
- •BMI < 18 or > 30 according to Chinese BMI references;
- •Generalized skin disease that may affect absorption of T (e.g., psoriasis) or a known skin intolerance to alcohol;
- •Prolactin > 40 mcg/L;
- •Untreated severe obstructive sleep apnea;.
- •Uncontrolled or poorly controlled heart failure
研究组 & 干预措施
Testogel 1% 5g QD
Experimental
干预措施: Testogel 1% (Drug)
Placebo gel 5g QD
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of patients with morning serum Total Testosterone concentration within the physiological range (300 - 1000 ng/dL or 10.4 - 34.7 nmol/L) after 3 months of Testogel treatment compared to placebo-treatment
时间窗: 3 months
次要结局
- morning serum Total Testosterone (TT) concentration compared to placebo treatment(3 months)
- morning serum Total Testosterone (TT) concentration compared to baseline values(3 months)
- serum concentrations of TT, calculated free testosterone (cFT), DHT, E2, LH, and FSH, SHBG(3 months)
- prostate assessments (PSA, urine flow rate, DRE, ultrasound B)(3 months)
- skin integrity(3 months)
研究者
研究点 (1)
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