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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal

Trial status

Country	Status	Recruitment Start
Portugal	Not yet recruiting	06.12.2024

Trial locations

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.

Investigated diseases:

Benign prostatic hyperplasia

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 ID:

2024-519076-75-00

Protocol code:

TryptoBPH

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?