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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate the Therapeutic Action of Tamsulosin and Finasteride in Symptomatic Benign Prostatic Hyperplasia (BPH) Patients

NCT02244229

Prostatic Hyperplasia

COMPLETED PHASE4

Observational Study of Tamsulosin in Patients With Benign Prostatic Hyperplasia

NCT02245555

Prostatic Hyperplasia

COMPLETED

Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

NCT01203371

Hyperplasia

WITHDRAWN PHASE3

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia

NCT00970632

Benign Prostatic Hyperplasia (BPH)

COMPLETED PHASE3

Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis

NCT00913315

Prostatitis

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

BPH LUTS(Lower Urinary Tract Symptoms)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center, parallel group, randomized clinical trial designed to evaluate the effect of treatment with 5-HTP, comparative to Tamsulosin, for a period of 6 months, on LUTS, changes in urine maximum flow rate (Qmax), prostate volume, erectile function and quality of life due to urinary symptoms in adult patients with BPH.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control arm

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

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

Oral medication, once a day for 6 months.

Experimental arm

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

Group Type EXPERIMENTAL

5-hidroxitriptophan

Intervention Type DRUG

Oral medication, 3 times a day for 6 months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tamsulosin

Oral medication, once a day for 6 months.

Intervention Type DRUG

5-hidroxitriptophan

Oral medication, 3 times a day for 6 months.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Omnic Cincofarm

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
* 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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No