Effect of Pasireotide LAR on Gonadotroph Adenomas: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI
研究概览
简要总结
The purpose of this study is to determine if administration of pasireotide LAR for one year to three patients with gonadotroph adenomas and elevated serum FSH concentrations will reduce the serum follicle-stimulating hormone (FSH) to normal and reduce the adenoma size.
详细描述
Gonadotroph adenomas are the most common pituitary macroadenomas. Currently no medical treatment as been found that decreases the size of these adenomas, so surgery is the only treatment. The reason to think that pasireotide might affect gonadotroph adenomas is that pasireotide binds avidly to somatostatin subtype 5 receptors, and gonadotroph adenomas express these receptors. For this study, three subjects who have gonadotroph adenomas, as judged by a macroadenoma of the pituitary and elevated serum FSH concentration, will be treated with a long-acting form of pasireotide once a month for one year. The effect of pasireotide on the size of the adenoma will be determined by MRI, and FSH secretion will be judged by the serum concentration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gonadotroph adenoma
排除标准
- •visual impairment attributable to the adenoma
- •radiation therapy
- •active gallbladder disease
- •uncontrolled diabetes
研究组 & 干预措施
Pasireotide LAR
80 mg IM once monthly
干预措施: pasireotide LAR (Drug)
结局指标
主要结局
Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI
时间窗: 12 months
MRI of the pituitary will be performed at baseline, Month 6 and Month 12 to demonstrate a decrease of ≥3 mm in at least two of three dimensions on MRI (cephalocaudal, transverse, and posterior-anterior). The outcome measure is defined as the number of participants who demonstrated a ≥3 mm decrease in adenoma size in two dimensions.
次要结局
- Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide.(12 months)