EUCTR2006-006354-98-FR进行中（未招募）1 期
Transdermal testosterone supplementation in elderly hypogonadal men with sarcopenia: effects on muscle function, physical performance, body composition and quality of life.”A randomized, double-blind, placebo-control, parallel-group study on 150 patients.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •- elderly men aged between 65 and 90 years
- •- AMS ³ 37
- •- Serum BT < 0.90 ng/mL
- •- Short Physical Performance Battery (SPPB) value between 4 and 9
- •- Body lean mass evaluation by Impedancemetry < -2 DS from normal value
- •- Serum total PSA £ 3 ng/mL
- •- Able to complete an informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Known acute or chronic prostate pathology, and/or PSA > 3 ng/mL, and/or suspicion of prostate cancer; familial history of prostate cancer
- •- Male breast cancer
- •- Severe cardiovascular, respiratory, hepatic, renal failure, or metabolic diseases/disorders
- •- Unstable angina, NYHA class III or IV congestive heart failure, or myocardial infarction within 3 months of entry
- •- Blood pressure > 160/90 mm Hg
- •- Hematocrit > 48%
- •- ALT and/or AST twice above the upper limit
- •- Uncontrolled hyper or hypothyroidism
- •- Limiting neuromuscular, joint or bone disease
- •- Documented sleep apnea
- •- Dementia, cognitive impairment or any psychiatric disease affecting subject’s ability to provide informed consent
- •- Rheumatoid arthritis, cirrhosis or active hepatitis
- •- History of stroke causing persistent motor deficit
- •- Uncontroled diabetic patients (type I or II)
- •- Acute illness in the prior 30 days
- •- Severe disability limiting strength or physical function testing
- •- Inability to perform hang-grip test
- •- Generalized dermatological disorders that might affect testosterone absorption or local tolerability assessment (hypertrichosis, psoriasis, eczema)
研究者
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