NCT00254553终止2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two Period Cross Over Trial to Validate Patient-Reported Outcome Measures for Use in Men With Late Onset Hypogonadism
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 150
- 主要终点
- Patient -reported outcome measures
研究概览
简要总结
Hypogonadal males, particularly those whose condition manifested later in life, may experience common symptoms associated with their hypogonadism. Questionnaires developed to assess these symptoms need to be tested. The primary purpose of this study is to test or validate the Patient-Reported Symptom Measure, Androgen Deficiency Quality of Life Questionnaire and the Patient Global Impression Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men with late-onset hypogonadism who are either on testosterone treatment or naïve of treatment:
- •have symptoms of androgen deficiency at screening (after wash-out if applicable) i.e. with a positive score on the Androgen Deficiency in the Aging Male (ADAM) Questionnaire (a "yes" answer to questions 1 or 7 or any three other questions).
- •morning total T levels of <=3 ng/mL (<=300 ng/dL; <=10.4 nmol/l) on two separate days prior to randomization (after appropriate wash-out, if applicable).
- •calculated free T <=0.074 ng/mL.
- •at least 50 and at most 75 years of age.
- •BMI of at least 18 kg/m^2 or at most 32 kg/m^2
- •Inclusion Criteria for Normogonadal Men:
- •morning total T levels <=3 ng/mL (<=300 ng/dL; <=10.4 nmol/L).
- •calculated free T <=0.074 ng/mL.
- •at least 50 and at most 75 years of age.
- •BMI of at least 18 kg/m^2 or at most 32 kg/m^2
排除标准
- •History or current diagnosis of prostate cancer or any clinically significant finding on prostate examination
- •Severe obstructive symptoms of benign prostate hypertrophy
- •Prostate specific antigen (PSA) levels greater than 4 ng/mL at screening
- •History or current diagnosis of carcinoma of the breast
- •Known chronic polycythemia and/or hematocrit greater than 50% at screening
- •Treatment-naïve subjects with hyperprolactinemia at screening (serum prolactin level >=50 ng/mL)
- •Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator
- •clinically significant abnormal physical finding prior to randomization
- •sensitive to trial medication or its components
- •History or presence of hepatic or renal disorder considered as clinically relevant in the opinion of the investigator.
- •Exclusion Criteria for Normogonadal Men:
- •Presence or previous diagnosis of androgen deficiency.
- •Previous or present use of testosterone preparations
- •Use of medication within the 12 weeks prior to the visit that may interfere with the objectives of the trial: hypothalamic/pituitary hormones and analogues (e.g., gonadotropins, ACTH, STH, Gn-RH agonists and antagonists, etc.); sex steroid
- •Any other disease that in the opinion of the investigator might compromise or confound the subject's symptomatology (e.g., presence of clinically significant depression or other psychiatric disorders, unstable endocrine disorder, sleep apnea, cardiovascular and cerebrovascular diseases, etc.)
研究组 & 干预措施
Arm 1
Active Comparator
Testim 1% (testosterone gel)
干预措施: Testim 1% (testosterone gel) (Drug)
Arm 2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Patient -reported outcome measures
时间窗: Baseline and after six weeks of treatment or placebo
次要结局
未报告次要终点
研究者
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