EUCTR2006-005200-13-DE进行中（未招募）不适用
Phase II multi-centre, randomised, open, comparative study of the safety and efficacyof transdermal testosterone (Testim®) compared to intramuscular testosteronedepot for the induction of puberty in boys with hypogonadism and delayed puberty - Testim® in delayed puberty
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •- Written informed consent
- •- Phenotypically and genotypically male patients
- •- Puberty stage G1
- •- Testicular volume <= 3ml
- •- Chronological age at least 14 years
- •- Bone age retarded > 1 year
- •- Morning (8-10 a.m.) testosterone < 0.8 nmol/l
- •- Hypogonadism: EITHER hCG test: failure of serum testosterone to rise in response to hCG (testosterone levels less than 2 times baseline) and spontaneous LH > 12 IU/l (hypergonadotrophic)
- •OR buserelin test: LH increase < 4 IU/l (hypogonadotrophic)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Previous treatment with testosterone for delayed puberty.
- •- Any syndrome that makes measurement of bone age difficult
- •- Planned operative treatment of gonadal dysfunction
- •- Functional testes tissue present (positive hCG test and LH values within normal range (12 IU/l or less))
- •- Severe metabolic disturbances, e.g. renal insufficiency affecting hormone function
- •- Patient or parents unable to give informed consent
- •- Patient unable/unlikely to follow study protocol
- •- Patient with psychological problems such as aggressive or inappropriate sexual behaviour that may be worsened by the treatment with testosterone
研究者
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