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临床试验/NCT00021814
NCT00021814已完成3 期

Medical Therapy of Prostatic Symptoms

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)17 个研究点 分布在 1 个国家目标入组 3,407 人开始时间: 1995年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
3,407
试验地点
17

研究概览

简要总结

The Medical Therapy of Prostatic Symptoms (MTOPS) is a clinical research study sponsored by the National Institutes of Health (NIH). The study will test whether the oral drugs finasteride (Proscar) and doxazosin (Cardura), alone or together, can delay or prevent further worsening of symptoms in men with Benign Prostatic Hyperplasia (BPH).

MTOPS is the largest and longest study to simultaneously test whether these drugs can delay or prevent the clinical progression (symptom worsening) of BPH. Seventeen U.S. medical centers recruited 2,931 men diagnosed with symptomatic BPH between December 1995 and March 1998. Study doctors will continue to follow these men through November 2001 on a quarterly basis. In addition to the clinical progression of BPH, MTOPS will include evaluations of prostate volume by ultrasound, prostate biopsies among a subgroup of volunteers, and quality of life.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Peak urinary flow rate at least 4 ml/sec but not greater than 15 ml/sec; and voided volume is at least 125 ml.
  • American Urological Association Symptom Score is greater than or equal to 8 and less than or equal to
  • Voluntarily signed the informed consent agreement prior to the performance of any study procedures.

排除标准

  • Serum prostate specific antigen level greater than 10 ng/ml.
  • Supine blood pressure less than 90/70 mmHG. Orthostatic hypotension.
  • Any prior medical or surgical intervention for BPH.
  • Received any prior experimental intervention (either medical or surgical) for prostate disease or enrolled in any other study protocol.

研究组 & 干预措施

Placebo

Placebo Comparator

Doxazosin and Finasteride placebos

干预措施: Doxazosin placebo (Drug)

Placebo

Placebo Comparator

Doxazosin and Finasteride placebos

干预措施: Finasteride placebo (Drug)

Doxazosin

Experimental

Doxazosin and Finasteride placebo

干预措施: Doxazosin (Drug)

Doxazosin

Experimental

Doxazosin and Finasteride placebo

干预措施: Finasteride placebo (Drug)

Finasteride

Experimental

Doxazosin placebo and Finasteride

干预措施: Finasteride (Drug)

Finasteride

Experimental

Doxazosin placebo and Finasteride

干预措施: Doxazosin placebo (Drug)

Combination

Experimental

Doxazosin and Finasteride

干预措施: Doxazosin (Drug)

Combination

Experimental

Doxazosin and Finasteride

干预措施: Doxazosin placebo (Drug)

研究者

研究点 (17)

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