Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients With BPH.
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
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.