BPHPhase 2TryptoBPHNCT05401032
Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH.
A Phase 2 study testing Tamsulosin and 5-hidroxitriptophan in people with BPH and LUTS(Lower Urinary Tract Symptoms), run by Clinical Academic Center (2CA-Braga) at 1 site in Portugal.
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… Read more about this study
- Who is it for?
- Ages 50 to 74 years, men only
- Conditions the study is for
- BPH, LUTS(Lower Urinary Tract Symptoms)
- What is being tested?
- Tamsulosin and 5-hidroxitriptophan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Dec 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Clinical Academic Center - Braga, Association (2CA-Braga)
Braga, 4710-243
Emanuel Dias, +351 253 027 249, emanueldias@med.uminho.pt
Joana Sousa, +351 253 027 249, coordenacao@ccabraga.org
About this study
Official title: TryptoBPH - Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH
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.
- Conditions
- BPH, LUTS(Lower Urinary Tract Symptoms)
- Being tested
- Tamsulosin, 5-hidroxitriptophan
- Keywords
- BPH, LUTS, 5-HTP, Oxitriptan, Tamsulosin
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Omnic
Oral medication, once a day for 6 months.
5-hidroxitriptophanDrug
Also called Cincofarm
Oral medication, 3 times a day for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | tamsulosin 0.4mg (once a day) for 6 months. Receives: Drug: Tamsulosin |
| Experimental arm | Experimental | 5-hidroxitriptophan 100 mg (3 times a day) for 6 months. Receives: Drug: 5-hidroxitriptophan |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (IPSS)
Evaluate the effect of tryptophan supplementation on lower urinary tract symptoms (LUTS)
Measured: Change from baseline to day 1, 1-month, 3- month and EOT (6-month)
Secondary outcomes (4)
Qmax
Urine maximum flow rate
Measured: Change from baseline to EOT (6-month)
IIEF-5
Erectile function, assessed by International Index of Erectile Function-5 (IIEF-5)
Measured: Change from baseline to EOT (6-month)
Prostate volume
Prostate volume (in cc), assessed by trans-rectal ultra-sound
Measured: Change from baseline to EOT (6-month)
question 8 of the IPSS
quality of life due to urinary symptoms (question 8 of the IPSS).
Measured: Change from baseline to EOT (6-month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start20 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Academic Center (2CA-Braga)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emanuel Dias, Principal investigator, Hospital de Braga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401032
- Sponsor's protocol ID
- TryptoBPH
- Other IDs
- 2024-519076-75-00, 2021-000946-16
- Acronym
- TryptoBPH
- Status last verified
- Jan 2025
- First submitted
- 25 May 2022
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TryptoBPH - Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH
- ClinicalTrials.gov ID
- NCT05401032
- Acronym / sponsor ID
- TryptoBPH / TryptoBPH
- Conditions
- BPH, LUTS(Lower Urinary Tract Symptoms)
- Keywords
- BPH, LUTS, 5-HTP, Oxitriptan, Tamsulosin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Clinical Academic Center (2CA-Braga)University, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Drug: Tamsulosintamsulosin 0.4mg (once a day) for 6 months. |
| Experimental arm | Experimental | Drug: 5-hidroxitriptophan5-hidroxitriptophan 100 mg (3 times a day) for 6 months. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamsulosinAlso: OmnicOral medication, once a day for 6 months. | Drug | Control arm |
| 5-hidroxitriptophanAlso: CincofarmOral medication, 3 times a day for 6 months. | Drug | Experimental arm |
Primary outcome
International Prostate Symptom Score (IPSS)
Time frame: 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)
4 secondary outcomes
Qmax
Time frame: Change from baseline to EOT (6-month)
IIEF-5
Time frame: Change from baseline to EOT (6-month)
Prostate volume
Time frame: Change from baseline to EOT (6-month)
question 8 of the IPSS
Time frame: Change from baseline to EOT (6-month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emanuel Dias principal investigator
Hospital de Braga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamsulosin and 5-hidroxitriptophan in people with BPH and LUTS(Lower Urinary Tract Symptoms), run by Clinical Academic Center (2CA-Braga) at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mónica Gonçalves (+351 253 027 249, 2ca@ccabraga.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (IPSS) (time frame: Change from baseline to day 1, 1-month, 3- month and EOT (6-month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.