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

ConditionsBPHLUTS(Lower Urinary Tract Symptoms)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Tamsulosin

    Drug

    Oral medication, once a day for 6 months.

  • 5-hidroxitriptophan

    Drug

    Oral medication, 3 times a day for 6 months.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Control armActive comparator 1 intervention
Group B: Experimental armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

International Prostate Symptom Score (IPSS)

Evaluate the effect of tryptophan supplementation on lower urinary tract symptoms (LUTS)

Time frame
Change from baseline to day 1, 1-month, 3- month and EOT (6-month)

Secondary outcomes

1

Qmax

Urine maximum flow rate

Time frame
Change from baseline to EOT (6-month)
2

IIEF-5

Erectile function, assessed by International Index of Erectile Function-5 (IIEF-5)

Time frame
Change from baseline to EOT (6-month)
3

Prostate volume

Prostate volume (in cc), assessed by trans-rectal ultra-sound

Time frame
Change from baseline to EOT (6-month)
4

question 8 of the IPSS

quality of life due to urinary symptoms (question 8 of the IPSS).

Time frame
Change from baseline to EOT (6-month)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinical Academic Center (2CA-Braga)

Lead sponsor

Source ClinicalTrials.gov
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