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

Sponsor
Clinical Academic Center (2CA-Braga) (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05401032
Collaborator
(none)
70
Enrollment
2
Arms
18
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Complete (double) blinding is not possible to achieve, nonetheless, in order to lessen assessment bias, efficacy and safety assessment procedures will be performed by the assigned blinded research staff. In order to assure blinding across the study, randomization data will be kept confidential and will not be accessible to anyone, except to unblinded research staff, pharmacy staff. Both groups will be monitored for the same study duration
Primary Purpose:
Treatment
Official Title:
TryptoBPH - Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients With BPH.
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control arm

tamsulosin 0.4mg (once a day) for 6 months.

Drug: Tamsulosin
Oral medication, once a day for 6 months.
Experimental: Experimental arm

5-hidroxitriptophan 100 mg (3 times a day) for 6 months.

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

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

  1. Qmax [Change from baseline to EOT (6-month)]

    Urine maximum flow rate

  2. IIEF-5 [Change from baseline to EOT (6-month)]

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

  3. Prostate volume [Change from baseline to EOT (6-month)]

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

  4. question 8 of the IPSS [Change from baseline to EOT (6-month)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Clinical Academic Center (2CA-Braga)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clinical Academic Center (2CA-Braga)
ClinicalTrials.gov Identifier:
NCT05401032
Other Study ID Numbers:
  • TryptoBPH
  • 2021-000946-16
First Posted:
Jun 2, 2022
Last Update Posted:
Jun 2, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Tamsulosin

Study Results

No Results Posted as of Jun 2, 2022