跳至主要内容
临床试验/EUCTR2012-002477-59-FI
EUCTR2012-002477-59-FI进行中(未招募)1 期

Constitutional Delay of Growth and Puberty: towards evidence-based treatment

Taneli Raivio, Helsingin yliopistollinen keskussairaala0 个研究点目标入组 50 人开始时间: 2012年11月20日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
50

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

入选标准

  • Clinical and biochemical criteria: Age 14 yrs or more, mean testicular volume >2.5 mL and <4mL, serum testosterone <5 nM and the adolescent wants medical intervention. No signs of chronic diseases accounting for the delayed puberty.
  • Biochemical criteria: As above, but serum testosterone >2 nM and normal serum DHEAS, even if the mean testicular volume is less than 2.5 ml.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 50
  • 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) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Chronic diseases, primary hypogonadism, chromosomal anomalies, chronic medication that potentially adversely affects bone mineralization (excluding inhaled corticosteroid treatment).

研究者

发起方
Taneli Raivio, Helsingin yliopistollinen keskussairaala

相似试验

已完成
2 期
Constitutional Delay of Growth and Puberty: Towards Evidence-based TreatmentConstitutional Delay of Growth and Puberty
NCT01797718Helsinki University Central Hospital35
已完成
4 期
Evaluation of Growth, Sexual Maturation, and Prolactin-Related Adverse Events in the Pediatric Population Exposed to Atypical Antipsychotic Drugs
NL-OMON34837Janssen-Cilag40
进行中(未招募)
不适用
Evaluation of Growth, Sexual Maturation, and Prolactin-Related Adverse Events in the Pediatric Population Exposed to Atypical Antipsychotic Drugsong-term safety data in children and adolescents will be collected from a population of patients with a diagnosis of schizophrenia, bipolar mania, autistic disorder or conduct and other disruptive disorders undergoing routine standard of care treatment.MedDRA version: 12.1Level: LLTClassification code 10039626Term: SchizophreniaMedDRA version: 12.1Level: HLGTClassification code 10026753Term: Manic and bipolar mood disorders and disturbancesMedDRA version: 12.1Level: LLTClassification code 10003805Term: Autism
EUCTR2009-012003-26-GRJanssen-Cilag International, NV350
进行中(未招募)
1 期
Evaluation of Growth, Sexual Maturation, and Prolactin-Related Adverse Events in the Pediatric Population Exposed to Atypical Antipsychotic Drugsong-term safety data in children and adolescents will be collected from a population of patients with a diagnosis of schizophrenia, bipolar mania, autistic disorder or conduct and other disruptive disorders undergoing routine standard of care treatment.MedDRA version: 12.1Level: LLTClassification code 10039626Term: SchizophreniaMedDRA version: 12.1Level: HLGTClassification code 10026753Term: Manic and bipolar mood disorders and disturbancesMedDRA version: 12.1Level: LLTClassification code 10003805Term: Autism
EUCTR2009-012003-26-BEJanssen-Cilag International, NV350
进行中(未招募)
不适用
Evaluation of Growth, Sexual Maturation, and Prolactin-Related Adverse Events in the Pediatric Population Exposed to Atypical Antipsychotic Drugsong-term safety data in children and adolescents will be collected from a population of patients with a diagnosis of schizophrenia, bipolar mania, autistic disorder or conduct and other disruptive disorders undergoing routine standard of care treatment.MedDRA version: 12.1Level: LLTClassification code 10039626Term: SchizophreniaMedDRA version: 12.1Level: HLGTClassification code 10026753Term: Manic and bipolar mood disorders and disturbancesMedDRA version: 12.1Level: LLTClassification code 10003805Term: Autism
EUCTR2009-012003-26-NLJanssen-Cilag International, NV350