TryptoBPH - Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH
概览
- 阶段
- 2 期
- 干预措施
- Tamsulosin
- 疾病 / 适应症
- BPH
- 发起方
- Clinical Academic Center (2CA-Braga)
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- International Prostate Symptom Score (IPSS)
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
Benign prostatic hyperplasia (BPH) is one of the most prevalent human diseases and a major cause of lower urinary tract symptoms (LUTS). Some men respond to current medical treatment (mainly α-1 adrenoreceptor antagonists and 5 α-reductase inhibitors), but a large proportion of patients continues to need a surgical procedure to treat resistant LUTS or even more serious complications of BPH, creating the emerging necessity for novel pharmacological therapies.
Oxitriptan may have a possible positive effect on BPH associated symptoms with probably no impact in sexual function (which is a common side effect of the current drugs for BPH associated symptoms). Also, improvement in symptoms could be higher than that of current drugs used for this condition.
This is a single-center parallel group, randomized clinical trial. The study will take place in Hospital de Braga (Urology department). Eligible patients will be randomized to receive tamsulosin 0.4mg (once a day, q.d.) or 5-HTP (5-hidroxitriptophan) 100mg (three times a day, t.i.d.), for 6 months.
研究者
入排标准
入选标准
- •Written informed consent;
- •Male patients with BPH for which tamsulosin is the therapeutic option per SoC;
- •Aged ≥50 and less than 75 years old;
- •With prostate volume ≥30 cm3 by TRUS;
- •Diagnosed with LUTS defined by a stable IPSS total score ≥13 points.
排除标准
- •Patients with post-void bladder residual volume ≥250 ml;
- •Patients with intravesical obstruction from any cause other than BPH;
- •History of any procedure considered an intervention for BPH;
- •Patients with active urinary tract infection;
- •History of recurrent urinary tract infections;
- •Current prostatitis or diagnosis of chronic prostatitis;
- •History of prostate or invasive bladder cancer;
- •Use of 5 α-reductase inhibitors within 6 months;
- •Phytotherapy within 2 weeks before entry;
- •Use of serotonin reuptake inhibitors or monoamine oxidase inhibitors;
研究组 & 干预措施
Control arm
tamsulosin 0.4mg (once a day) for 6 months.
干预措施: Tamsulosin
Experimental arm
5-hidroxitriptophan 100 mg (3 times a day) for 6 months.
干预措施: 5-hidroxitriptophan
结局指标
主要结局
International Prostate Symptom Score (IPSS)
时间窗: Change from baseline to day 1, 1-month, 3- month and EOT (6-month)
Evaluate the effect of tryptophan supplementation on lower urinary tract symptoms (LUTS)
次要结局
- IIEF-5(Change from baseline to EOT (6-month))
- Qmax(Change from baseline to EOT (6-month))
- Prostate volume(Change from baseline to EOT (6-month))
- question 8 of the IPSS(Change from baseline to EOT (6-month))