NCT01768676已完成4 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Clinical Trial of the Effect of Avanafil (STENDRA™) on Spermatogenesis in Healthy Adult Males and Adult Males With Mild Erectile Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- VIVUS LLC
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- Percentage of Subjects With a Greater Than or Equal to 50% Decrease in Sperm Concentration From Baseline to Week 26
研究概览
简要总结
The purpose of this study is to determine whether avanafil will affect different aspects of sperm production.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provide written informed consent
- •Able to produce semen samples without requiring therapy (PDE5 inhibitors, over-the-counter (OTC) medication, and/or herbal supplements) for erectile dysfunction
- •Be medically healthy (no clinically significant screening results for medical history, electrocardiogram (ECG), laboratory studies, physical examination, etc.) in the opinion of the investigator
- •Be willing and able to comply with all study requirements
排除标准
- •An International Index of Erectile Function (IIEF) erectile function domain score of less than 17;
- •History of infertility, vasectomy, testicular mass, testicular trauma, testicular abnormality (including size), radiation to the testis, previous pelvic surgery, cryotherapy of the prostate, known sperm defect, or retrograde ejaculation, or cryptorchidism;
- •Resting heart rate <45 or >90 beats per minute at screening (3 rechecks permitted);
- •Screening systolic blood pressure <90 or >140 mmHg and/or diastolic blood pressure <50 or >90 mmHg (3 rechecks permitted);
- •High serum FSH (>18.0 mIU/mL), high serum LH (>18 mIU/mL), or low serum testosterone (< 270 ng/dL, early morning collection) on screening;
- •AST or ALT >2.0 x ULN or other evidence of significant hepatic impairment;
- •Prostate specific antigen (PSA) level ≥4 ng/mL at screening;
- •Individuals who perform rotating shift work during the course of the study.
研究组 & 干预措施
Placebo
Placebo Comparator
placebo
干预措施: Placebo (Drug)
avanafil
Experimental
100 mg
干预措施: avanafil (Drug)
结局指标
主要结局
Percentage of Subjects With a Greater Than or Equal to 50% Decrease in Sperm Concentration From Baseline to Week 26
时间窗: Baseline to Week 26
Subjects provided 2 semen samples at each visit 2 to 12 days apart. The average value is used as the visit result.
次要结局
- Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26(baseline to week 26)
- Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Motility From Baseline to Week 26(baseline to week 26)
- Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From Baseline to Week 26(baseline to week 26)
- Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26(baseline to week 26)
研究者
研究点 (1)
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