NCT00062790已完成4 期
Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 12
- 主要终点
- Effect of repeat oral daily dosing of 0.5mg dutasteride compared to placebo on prostate tissue content of DHT in patients treated for 3 months prior to transurethral resection of the prostate (TURP).
研究概览
简要总结
This study is being done to determine how much certain hormone levels in the prostate decrease when a patient takes dutasteride 0.5mg daily for 3 months prior to TURP. Male patients at least 50 years old willing to take either dutasteride or a placebo (dummy pill) once daily by mouth for 3 months prior to having a surgery to reduce the size of their prostate. During the surgery, very small pieces of the prostate that are removed will be tested to see how much dihydrotestosterone and testosterone (male hormones) are in the tissue.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with benign prostatic hyperplasia
- •Must be scheduled to have a transurethral resection of the prostate (prostate surgery) and be able to wait 3 months to have the procedure.
- •PSA (prostate specific antigen) level must be between 1.5 and 15 ng/ml.
排除标准
- •Prostate cancer.
- •Use of saw palmetto or other over the counter treatments for prostate health chemically related to the study medication.
- •Previous finasteride use or other investigational 5ARI within 6 months prior to screening.
- •History of chronic UTIs (urinary tract infections)
- •Presence of acute bacterial prostatitis at screening
结局指标
主要结局
Effect of repeat oral daily dosing of 0.5mg dutasteride compared to placebo on prostate tissue content of DHT in patients treated for 3 months prior to transurethral resection of the prostate (TURP).
次要结局
- Changes in serum DHT (dihydrotestosterone) and T (testosterone).
- Effect of repeat oral once daily dosing of 0.5mg dutasteride compared to placebo on prostatic tissue content of testosterone.
研究者
研究点 (12)
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