Markers of Adequate Pubertal Suppression During Supprelin LA Therapy for Central Precocious Puberty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of free alpha subunit of pituitary glycoprotein to identify subjects with appropriate pubertal suppression.
研究概览
简要总结
The best way to measure whether treatment of children with central precocious puberty is working is to do a hormone stimulation test (leuprolide stimulation test) that requires injection of a medication and multiple blood draws to see if the hormonal response is suppressed (blocked). The hypothesis of this study is that random measurement of the free alpha subunit of pituitary glycoprotein, a protein related to the pituitary hormones that stimulate puberty, will provide an adequate alternative to the leuprolide stimulation testfor monitoring efficacy of pubertal suppression with Supprelin LA®.
详细描述
During clinical trials of Supprelin LA®, leuprolide stimulation tests were performed to determine adequacy of suppression. However, the use of this stimulation test to monitor suppression requires an expensive medication and collection of multiple blood samples. Alternative methods of monitoring pubertal suppression during gonadotropin releasing hormone receptor agonist (GnRHa) therapy have included both random and trough levels of Luteinizing Hormone (LH), estradiol or inhibin B. Recently, the free alpha subunit of pituitary glycoprotein (FASPG) has also been shown to be a potentially useful marker of hormonal suppression (Hirsch HJ, et al, JCEM 95:2841, 2010) as it undergoes a paradoxical rise following initiation of therapy, and reverts to baseline upon completion.
In this investigator-initiated pilot study we will evaluate novel markers of pubertal suppression in children receiving standard of care gonadotropin releasing hormone receptor agonist therapy for the treatment of central precocious puberty. Children with central precocious puberty who have selected treatment with Supprelin LA will undergo hormonal testing of markers of pubertal activity before and after placement of the Supprelin LA insert.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 3 to 9 years old, inclusive
- •Diagnosis of Central Precocious or Rapidly Progressive Puberty
- •Bone Age more than 1 year advanced (obtained within 6 months of screening) AND
- •Breasts Tanner II or greater AND
- •One of the following:
- •Random LH > 1 mIU/mL
- •Leuprolide-stimulated LH > 4 mIU/mL
- •Random estradiol > 20 pg/mL
- •Leuprolide-stimulated 24 hour estradiol >20 pg/mL
- •Naïve to GnRHa therapy
- •Approved to receive Supprelin LA® therapy
- •Have an acceptable surrogate capable of giving consent on the subject's behalf.
排除标准
- •Previous GnRHa therapy
- •Presence of peripheral precocious puberty including CAH
结局指标
主要结局
Sensitivity and specificity of free alpha subunit of pituitary glycoprotein to identify subjects with appropriate pubertal suppression.
时间窗: Up to 12 months
The primary outcome of the study will be the sensitivity and specificity of a subject having elevated random FASPG values (\> 0.6 ng/mL) to identify subjects who are appropriately suppressed based upon a leuprolide-stimulated LH \<4 mIU/mL. This outcome will be based upon results of puberty hormone suppression testing obtained 28-97 days after placement of the Supprelin LA insert.
次要结局
未报告次要终点