NCT00290134已完成2 期
Preliminary Efficacy and Safety of Fispemifene in the Treatment of Hypogonadism: A 4 Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Daily Oral Doses of 100, 200, and 300 mg Fispemifene and Placebo
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 17
- 主要终点
- Change in morning total testosterone levels from baseline to Week 4 (end of therapy)
研究概览
简要总结
The purpose of this study is to determine whether one or more fispemifene dose regimens are more effective than placebo in the treatment of hypogonadism in older men.
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
- Double
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Total testosterone level <240 ng/dL
- •Serum LH and FSH levels within normal limits
排除标准
- •Elevated prolactin
- •Evidence of Benign Prostatic Hypertrophy
- •History of or current breast cancer, prostate cancer, abnormal DRE or elevated PSA or any other malignancy
- •Clinically significant endocrine/metabolic or cardiovascular disease
- •Significant polycythemia
结局指标
主要结局
Change in morning total testosterone levels from baseline to Week 4 (end of therapy)
次要结局
- Change in total testosterone levels from baseline to Weeks 2 and 6
- Change in free testosterone, calculated free testosterone, and DHT from baseline to Weeks 2, 4, and 6
- Change in SHBG, E2, LH, FSH and inhibin B from baseline to Weeks 2, 4, and 6
研究者
研究点 (17)
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