NCT00434824已完成2 期
A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Oral Administration of Different Doses of Org 538 in Symptomatic Aging Men With Androgen Deficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 322
- 主要终点
- Change from baseline on the total score of the AMS rating scale
研究概览
简要总结
In this study we have evaluated the effects of three different doses of oral testosterone undecanoate in aging men presenting with a combination of symptoms suggestive of hypogonadism and low blood levels of the male hormone testosterone.
Specifically, we have studied the effects on:
- symptoms suggestive of low testosterone levels
- blood testosterone and other hormone levels
- bone mass
- muscle mass and fat mass
- muscle strength
- prostate
- lipids, hematocrit
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects were at least 50 years of age
- •A body mass index (BMI) between 18 and 34 kg/m^2
- •Symptoms of androgen deficiency (as indicated by a positive Androgen Deficiency in Aging Males (ADAM) questionnaire)
- •Calculated free testosterone measurement of <0.26 nmol/L in the morning
排除标准
- •History or current diagnosis of breast or prostate cancer
- •any clinically significant abnormal finding on physical examination including the prostate
- •Clinical symptoms of obstructive benign prostate hyperplasia (International Prostate Symptom Score (IPSS) >14)
- •Prostate specific antigen (PSA) level > 4 ng/mL at screening
- •Cause of androgen deficiency other than aging, e.g. 'classical' diagnosis of primary or secondary hypogonadism
- •Hyperprolactinaemia or treatment with prolactin-lowering drugs
- •History of known chronic polycythemia and/or hematocrit >50% at screening
- •History or presence of severe sleep apnea
- •Unstable or untreated endocrine disorders
- •History or presence of clinically significant depression or other psychiatric disorder or any clinically relevant cardiovascular, cerebrovascular, endocrine, hepatic, renal or hematological disease, thromboembolism/thrombosis etc. which, in the opinion of the investigator, might compromise the subject's participation in the trial
- •Use of medication that would interfere with the efficacy and safety objectives of the trial
研究组 & 干预措施
Arm 1
Active Comparator
Oral testosterone undecanoate (Andriol)
干预措施: Oral testosterone undecanoate (Andriol) (Drug)
Arm 2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline on the total score of the AMS rating scale
时间窗: Month 6
次要结局
- Effects on AMS rating scale, bone mineral density, bone markers, muscle and fat mass, muscle strength, hematocrit, endocrine parameters, PSA, IPSS and lipids(Month 12)
研究者
相似试验
已完成
3 期
Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal MenMale HypogonadismNCT01403116Clarus Therapeutics, Inc.325
已完成
3 期
Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or HypogonadismMale HypogonadismNCT02081300Lipocine Inc.315
已完成
3 期
Safety and Efficacy Trial of Testosterone UndecanoateMale HypogonadismNCT01765179Clarus Therapeutics, Inc.144
已完成
2 期
Efficacy of an Intranasal Testosterone ProductHypogonadismNCT01252745Acerus Pharmaceuticals Corporation22
已完成
4 期
Trial of Testosterone Undecanoate for Optimizing Performance During Military OperationsCaloric RestrictionExerciseSleepNCT04120363Pennington Biomedical Research Center34