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Study on the Safety and Effectiveness of Oxitriptan and Tamsulosin Hydrochloride for Patients with Benign Prostatic Hyperplasia

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for Benign Prostatic Hyperplasia (BPH), a condition where the prostate gland is enlarged, which can cause urinary problems. The study will use a treatment involving tryptophan, a substance that is being evaluated for its potential to improve symptoms related to BPH. The trial will also involve the use of tamsulosin hydrochloride, a medication commonly used to treat BPH symptoms.

The purpose of the study is to assess the safety and effectiveness of tryptophan in patients with BPH. Participants will receive either tryptophan or a placebo, alongside their regular treatment with tamsulosin hydrochloride. The study will last for a period of six months, during which participants will take the medication orally in the form of capsules or tablets. The study aims to observe changes in urinary symptoms and overall quality of life related to urinary health.

Throughout the study, participants will be monitored for any changes in their condition, including improvements in urinary flow and prostate size. The study will use the International Prostate Symptom Score (IPSS) to evaluate the severity of urinary symptoms. This trial is an important step in understanding how tryptophan might help manage symptoms of BPH and improve the lives of those affected by this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, prostate volume, and symptom score.

    Eligibility criteria include being a male aged between 50 and 74 years, having a prostate volume of at least 30 cm³, and a stable symptom score of 13 or more points.

  2. Step 2

    Medication administration

    Participants receive two medications: oxitriptan and tamsulosin hydrochloride.

    Oxitriptan is administered orally in the form of a hard capsule, known as Cincofarm 100 mg.

    Tamsulosin hydrochloride is administered orally as a prolonged-release tablet, known as Omnic 0.4 mg.

    The dosage and frequency of administration are determined by the study protocol and are explained during the initial assessment.

  3. Step 3

    Monitoring and evaluation

    Participants are monitored regularly to evaluate the effect of the medication on urinary symptoms.

    The primary measure of success is the change in the total score of the International Prostate Symptom Score (IPSS) questionnaire.

    Secondary measures include urine flow rate, erectile function, prostate volume, and quality of life related to urinary symptoms.

  4. Step 4

    Study duration

    The study is expected to continue until December 6, 2026.

    Participants are required to adhere to the study schedule and attend all follow-up appointments as outlined in the study protocol.

Who can join the trial?

6 criteria

  • You must provide written informed consent before any assessment is performed. This means you agree to participate after understanding the study details.
  • You must be a male patient with benign prostatic hyperplasia. This is a condition where the prostate gland is enlarged but not cancerous.
  • The medication option for your condition should be tamsulosin, as per the standard of care (SoC).
  • You must be aged 50 years or older, but less than 75 years old.
  • Your prostate volume must be 30 cubic centimeters or more, as measured by a test called TRUS (transrectal ultrasound).
  • You must have been diagnosed with LUTS (lower urinary tract symptoms), with a stable score of 13 points or more on the IPSS (International Prostate Symptom Score). This score helps measure the severity of urinary symptoms.

Who cannot join the trial?

3 criteria

  • Patients who are not male cannot participate in the study.
  • Patients who do not have a condition called benign prostatic hyperplasia cannot participate. This is a condition where the prostate gland is enlarged but not cancerous.
  • Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection, like children or people with certain disabilities.
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Investigated drugs

Tryptophan is being studied to see if it can help improve symptoms in patients with benign prostatic hyperplasia (BPH). BPH is a condition where the prostate gland is enlarged, which can cause urinary problems. The trial aims to find out if taking tryptophan can reduce these urinary symptoms and improve the quality of life for patients.

What is already known about the treatment

Tryptophan – Tryptophan is administered orally in the form of dietary supplements. It is currently being studied in clinical trials for its potential benefits in treating benign prostatic hyperplasia (BPH). The main therapeutic indication for tryptophan in this context is to alleviate lower urinary tract symptoms associated with BPH. At the molecular level, tryptophan is an essential amino acid that serves as a precursor to serotonin, which may influence urinary function. It is classified pharmacologically as an amino acid supplement.

Investigated diseases

Benign prostatic hyperplasia – This condition involves the enlargement of the prostate gland, which is common in older men. As the prostate enlarges, it can press against the urethra, leading to difficulties with urination. Symptoms often include a frequent need to urinate, especially at night, a weak urine stream, and a feeling that the bladder is not completely empty after urination. The progression of the disease can lead to more pronounced urinary symptoms and discomfort. Over time, the bladder may become weaker, and the ability to empty it fully may decrease. This condition is not cancerous, but it can significantly affect the quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519076-75-00Protocol codeTryptoBPHEstimated enrolment70 patientsSponsorCCAB Centro Clinico Academico Braga Associacao

sourced from the EU Clinical Trials Register and site verification

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