Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age50-74
SponsorClinical Academic Center (2CA-Braga)
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Tamsulosin
- 5-hidroxitriptophan
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov