EUCTR2004-000384-10-FR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 (Biclutamide anatrozole treatment for testotoxicosis)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •1. Provision of written informed consent of parent/ legal guardian and subject assent
- •(as needed by local requirements)
- •2. Male aged 2 years and over
- •3. Diagnosis of testotoxicosis based on the following:
- •-clinical features of:
- •i) progressive sexual precocity documented by Tanner staging and evidence of
- •symmetrical testicular enlargement
- •ii) 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 gonadotropins
- •- lack of an increase in serum gonadotropin levels following GnRH stimulation
- •- other pathology excluded by:
- •i) undetectable plasma b human chorionic gonadotropin (bHCG)*
- •*Samples with values below the LOQ will be reported as <10 IU/L which in the clinical setting equate to 'undetectable'.
- •ii) normal levels of 17-hydroxyprogesterone (17-OHP)
- •iii) normal levels of dehydroepiandrosterone sulphate (DHEAS)
- •4. Naïve to anti androgen receptor therapy (Note: Ketoconazole and spironolactone are considered acceptable as is prior use of anastrozole or other aromatase inhibitors)
- •5. A documented reliable height measurement taken at least 6 months prior to study
- •enrolment. 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 at leats 6 months prior to study entry)
- •6. 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 the longer) washout period from prior medication for
- •testotoxicosis
- •Are the trial subjects under 18? yes
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Evidence of central precocious puberty as demonstrated by GnRH stimulation test
- •2. Serum concentration of total or direct bilirubin, GGT, AST or ALT greater than 1.5
- •times the upper limit of normal for age
- •3. Serum concentration of creatinine greater than 1.5 times the upper limit of normal
- •4. 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
- •5. Known hypersensitivity to any of the study medications
- •6. Participation in a clinical study at the time of enrolment
研究者
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