Anastrozole Administration in Elderly Hypogonadal Men
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change in Lean Body Mass
研究概览
简要总结
The purpose of the study is to assess the effects of sustained aromatase inhibitor therapy to reduce estrogen levels in elderly men with mild hypogonadism (a decreased level of sex hormones).
详细描述
It has long been accepted that aging in men is associated with a slow, steady decline in gonadal androgen (male sex hormone) production. Several studies have explored androgen replacement, but the safety and efficacy of testosterone administration remains controversial. Aromatase inhibitors may provide a particularly useful way to restore normal androgen production in aging men.
This study will recruit 150 male volunteers, 60 years of age or older, to be randomized to receive either anastrozole or a placebo for 24 months. Six visits are planned over the 96-week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men ages 60 and older
- •Serum testosterone between 150-300 ng/dL
- •Symptoms suggestive of androgen deficiency
排除标准
- 未提供
研究组 & 干预措施
placebo
placebo
干预措施: anastrozole (Drug)
anastrozole
anastrozole
干预措施: anastrozole (Drug)
结局指标
主要结局
Change in Lean Body Mass
时间窗: Baseline and 1 year
次要结局
未报告次要终点
研究者
Benjamin Leder, MD
Principal Invesitgator (MD)
Massachusetts General Hospital