EUCTR2012-001180-77-Outside-EU/EEA进行中（未招募）不适用
An open-label, non-comparative, multi-centre study to assess the efficacy and safety of bicalutamide when used in combination with anastrozole for the treatment of gonadotropin-independent precocious puberty in boys with testotoxicosis. - BATT study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 14
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
- •Provision of written infromed consent of parent/legal guardian and subject assent (as needed by local requirements)
- •Male aged 2 years and over
- •Diagnosis of testotoxicosis based on:
- •- Cinical features of progressive sexual precocity documented by Tanner staging and evidence of symmetrical testiclular enlargement;
- •- Clinical features of significantly advanced bone age (defined as bone age of at least 12 months beyond chronological age);
- •- pubertal levels of serum testosterone;
- •- prepubertal levels of serum gonadotrophins;
- •- lack of an increase in serum gonadotrophin levels following GnRH stimulation.
- •Other pathology excluded by:
- •- undetectable plasma b human chorionic gonadotroin (bHCG). Samples with values below the LOQ will be reported as <10 IU/L which in the clinical setting equate to 'undetectable';
- •- normal levels of 17-hydroxyprogesterone (17-OHP);
- •- normal levels of dehydroepiandrosterone sulphate (DHEAS)
- •Naive to anti androgen receptor therapy:
- •(Note: ketoconazole and Spironolactone are considered acceptable as is prior use of anastrozole or other aromatose inhibitors)
- •A documented reliable height measurement taken > 6 months prior to study enrollment. Additionally for subjects who have previously received ketoconazole or spironolactone treatment, a documented reliable height measurement taken immediately prior to beginning this treatment.
- •(Note: for subjects who received such previous treatment only a single assessment is needed if it was taken immediately prior to beginning treatment and > 6 months prior to study entry)
- •Subjects should be free of endocrine or other effects of previous treatment for testotoxicosis prior to study entry: to ensure this there should be 15 days or 4 drug half lives (whichever is longer) washout period from prior medication for testotoxicosis.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 14
- •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
- •Evidence of central precocious puberty as demonstrated by GnRH stimulation test.
- •Serum concentration of total or direct bilirubin, GGT, AST or ALT greater than 1.5 times the upper limit of normal for age.
- •Serum concentration of creatinine greater than 1.5 times the upper limit of normal for age.
- •Any concomitant medical condition that, in the opinion of the investigator, may expose a subject to an unacceptable level of safety risk or that affects subject compliance.
- •Known hypersensitivity to any of the study medications.
- •Participation in a clinical study at the time of enrollment.
研究者
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