NCT00894517已完成1 期
A Study Evaluating the Effect of Botulinum Toxin Type A on Semen Quality in Patients With Benign Prostatic Hyperplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 61
- 主要终点
- Percent Change in Total Sperm Count Per Ejaculate
研究概览
简要总结
This is a 24 week study evaluating the effects of botulinum toxin Type A on semen quality in patients with signs and symptoms of Benign Prostatic Hyperplasia (BPH).
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
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Symptoms due to an enlarged prostate
- •Able to provide semen samples at required visits.
排除标准
- •Previous use of any botulinum toxin for the treatment of any urological condition
- •History of vasectomy
- •History of undescended testicles or testicular trauma
- •Subject who has not ejaculated for greater than 1 year
- •History of prostate infection or any sexually transmitted disease, such as gonorrhea, within the previous 12 months
- •History of bladder stones
- •History of cancer in the prostate, testicles, or bladder
- •Previous use of chemotherapy for cancer treatment
- •History of urinary incontinence
- •Previous prostate surgery
研究组 & 干预措施
Botulinum Toxin Type A
Experimental
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
干预措施: Botulinum Toxin Type A (Biological)
Placebo (saline)
Placebo Comparator
Placebo (saline) injected into the prostate on Day 1.
干预措施: Placebo (saline) (Drug)
结局指标
主要结局
Percent Change in Total Sperm Count Per Ejaculate
时间窗: Baseline, Week 12
Sperm count per ejaculate was calculated based on the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Ejaculatory volume and sperm concentration were used to determine the total sperm count per ejaculate. A positive percent change from Baseline indicated improvement.
次要结局
- Change From Baseline in Ejaculatory Volume(Baseline, Week 12)
- Change From Baseline in Total Sperm Motility(Baseline, Week 12)
- Change From Baseline in Log Transformed Sperm Concentration(Baseline, Week 12)
- Change From Baseline in Normal Sperm Morphology(Baseline, Week 12)
研究者
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