Efficacy of Testosterone Replacement Therapy in Penile Rehabilitation Following Radical Prostatectomy (#: 04-07-30-01)
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- Mohit Khera
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit.
研究概览
简要总结
The purpose of this study is to determine the effectiveness of testosterone replacement therapy (TRT) in men following surgery to remove the prostate in improving erectile function. Subjects will be randomized (like flipping a coin) to one of two groups. One group will receive Testim® (testosterone gel) 5 g per day plus Viagra 25 mg every night and the other will receive Placebo-Testim® 5 g per day plus Viagra 25 mg every night.
Subjects will begin drug treatment 3 months after the initial screening visit and will take study drug for 3 months only. Participation will end at the end of the 6-month visit.
详细描述
There was only one patient who began treatment with the study drug. After blind was broken, it was noted that he received placebo Testim and Viagra.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males, 18 years of age or older, with low testosterone levels.
- •Must have undergone a bilateral nerve sparing radical prostatectomy.
- •Nadir PSA (Prostate-Specific Antigen) values should be less than 0.01 ng/ml on two consecutive occasions separated by 4 weeks at the start of treatment.
- •Must give informed consent.
- •Must be willing to complete follow-up visits.
排除标准
- •Testosterone level greater than 300 ng/ dl
- •Hemoglobin level greater than 18 ng/dl.
- •Positive surgical margins or evidence of residual prostate cancer after surgery.
- •Clinically suspected advanced disease or actual evidence of metastatic prostate cancer.
- •Primary Gleason Grade greater than 3 or secondary Gleason Grade greater than 4 in the final pathologic specimen will be excluded.
- •Taking nitrates or with contraindications to the use of Viagra or androgen therapy will be excluded.
- •Known hypersensitivity to any component of the tablet will be excluded.
研究组 & 干预措施
Testim® + Viagra®
Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
干预措施: Testim® (Drug)
Testim® + Viagra®
Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
干预措施: Viagra® (Drug)
Placebo Testim® + Viagra®
Placebo Testim® gel once daily + Viagra® 25 mg tablet every night
干预措施: Placebo Testim® (Other)
Placebo Testim® + Viagra®
Placebo Testim® gel once daily + Viagra® 25 mg tablet every night
干预措施: Viagra® (Drug)
结局指标
主要结局
Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit.
时间窗: Baseline and 6 months
SHIM range is 0-25. 0= no sexual activity;1-7 severe ED; 8-11 Moderate ED; 12-16 Mild to Moderate ED; 17-21 Mild ED
次要结局
- Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.(Baseline and 6 months)
- Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit.(Baseline and 6 months)
- Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.(Basline and 6 months)
研究者
Mohit Khera
Assistant Professor
Baylor College of Medicine