Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH.

Официальное название

TryptoBPH - Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH

Обзор

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.

Вмешательства

• Препарат Tamsulosin
  Oral medication, once a day for 6 months.
• Препарат 5-hidroxitriptophan
  Oral medication, 3 times a day for 6 months.

Первичные конечные точки

• International Prostate Symptom Score (IPSS) [Срок оценки: Change from baseline to day 1, 1-month, 3- month and EOT (6-month)]

Вторичные конечные точки (4)

• Qmax [Срок оценки: Change from baseline to EOT (6-month)]
• IIEF-5 [Срок оценки: Change from baseline to EOT (6-month)]
• Prostate volume [Срок оценки: Change from baseline to EOT (6-month)]
• question 8 of the IPSS [Срок оценки: Change from baseline to EOT (6-month)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;
• Patients with acute or chronic kidney failure;
• Patients with diagnosed or suspicion of intolerance to lactose;
• Patients submitted to general anesthesia in the past 4 weeks;
• Known intellectual disability that may hampers giving informed consent and would make the patient inappropriate for entry into this study, in the judgment of the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Португалия · 1 центр

• Clinical Academic Center - Braga, Association (2CA-Braga) — Braga

Идентификаторы

NCT: NCT05401032 · TryptoBPH · 2024-519076-75-00 · 2021-000946-16

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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