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

BPH Clinical Trial

— TryptoBPH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05401032
• Other study ID #: TryptoBPH
• Secondary ID: 2021-000946-16
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2022
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: Clinical Academic Center (2CA-Braga)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• patients with post-void bladder residual volume =250 ml; TryptoBPH Version 1.4 (December 6th, 2021) Page 8 of 45

• 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 a-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.

Related Conditions & MeSH terms

• BPH

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Academic Center (2CA-Braga)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Prostate Symptom Score (IPSS)	Evaluate the effect of tryptophan supplementation on lower urinary tract symptoms (LUTS)	Change from baseline to day 1, 1-month, 3- month and EOT (6-month)
Secondary	Qmax	Urine maximum flow rate	Change from baseline to EOT (6-month)
Secondary	IIEF-5	Erectile function, assessed by International Index of Erectile Function-5 (IIEF-5)	Change from baseline to EOT (6-month)
Secondary	Prostate volume	Prostate volume (in cc), assessed by trans-rectal ultra-sound	Change from baseline to EOT (6-month)
Secondary	question 8 of the IPSS	quality of life due to urinary symptoms (question 8 of the IPSS).	Change from baseline to EOT (6-month)