Benign Prostatic HyperplasiaPhase 4DTT-BPHNCT07715448
Effect of Different Dosing Regimens of Tadalafil or Tamsulosin Combined With 5α-Reductase Inhibitors on Urinary and Sexual Outcomes in Benign Prostatic Hyperplasia
A Phase 4 study testing Tamsulosin, Tadalafil and 5-Alpha Reductase Inhibitor in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Benign prostatic hyperplasia (BPH) is a common condition among aging men that causes lower urinary tract symptoms (LUTS) and may negatively affect sexual function. This randomized single-blind controlled clinical trial compares the efficacy, safety, and sexual outcomes of different dosing regimens of tadalafil or… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Erectile Dysfunction
- What is being tested?
- Tamsulosin, Tadalafil and 5-Alpha Reductase Inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- Start not givento 1 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male participants aged 50 years or older.
- Newly diagnosed with benign prostatic hyperplasia (BPH).
- Moderate to severe lower urinary tract symptoms (LUTS), defined as International Prostate Symptom Score (IPSS) > 7.
- Prostate volume >40 mL confirmed by transrectal ultrasonography (TRUS).
- Sexually active with a baseline International Index of Erectile Function-Erectile Function (IIEF-EF) score >10.
- Prostate-specific antigen (PSA) <4 ng/mL and no suspicious findings on digital rectal examination (DRE).
- Able and willing to provide written informed consent.
Who cannot join
- History of prostate cancer.
- Previous prostate surgery.
- Abnormal digital rectal examination suggestive of malignancy.
- Severe erectile dysfunction (IIEF-EF score ≤10).
- Uncontrolled diabetes mellitus.
- Uncontrolled cardiovascular disease.
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- Neurological disorders affecting bladder function.
- Renal impairment.
- Hepatic impairment.
- Active urinary tract infection.
- Bladder stones or other significant urological pathology.
- Known hypersensitivity to tamsulosin, tadalafil, or 5-alpha reductase inhibitors.
- Patients actively seeking fertility treatment.
- Current use of medications known to significantly affect sexual function.
- Concurrent use of nitrates or contraindicated antihypertensive medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Effect of Different Dosing Regimens of Tadalafil or Tamsulosin Combined With 5α-Reductase Inhibitors on Urinary and Sexual Outcomes in Benign Prostatic Hyperplasia: A Comparative Clinical Trial Study"
Benign prostatic hyperplasia (BPH) is a common condition among aging men that causes lower urinary tract symptoms (LUTS) and may negatively affect sexual function. This randomized single-blind controlled clinical trial compares the efficacy, safety, and sexual outcomes of different dosing regimens of tadalafil or tamsulosin combined with 5-alpha reductase inhibitors (5ARIs) in men with BPH and enlarged prostate volume. A total of 240 participants were randomly assigned to six treatment groups and followed for 12 weeks. Changes in urinary symptoms, erectile function, ejaculatory function, prostate volume, prostate-specific antigen (PSA), urinary flow rate, post-void residual volume, and adverse events were evaluated to determine the optimal combination regimen.
Read the detailed description
Benign prostatic hyperplasia (BPH) is one of the most common causes of lower urinary tract symptoms (LUTS) in older men and is frequently associated with impaired sexual function. Alpha-blockers and 5-alpha reductase inhibitors (5ARIs) are widely used for medical management; however, both treatment strategies may adversely affect sexual function. Phosphodiesterase type-5 inhibitors, particularly tadalafil, have emerged as an alternative therapeutic option because they improve LUTS while preserving erectile function.
This randomized, single-blind, controlled clinical trial was conducted at the Department of Urology, Faculty of Medicine, Beni-Suef University, Egypt. The study enrolled 240 eligible men aged 50 years or older with moderate-to-severe LUTS secondary to BPH and prostate volume greater than 40 mL. Participants were randomly allocated into six equal treatment groups comparing different dosing regimens of tadalafil or tamsulosin combined with 5-alpha reductase inhibitors.
The primary objective was to compare improvements in lower urinary tract symptoms using the International Prostate Symptom Score (IPSS). Secondary objectives included evaluation of erectile function using the International Index of Erectile Function-Erectile Function domain (IIEF-EF), ejaculatory function using the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD), maximum urinary flow rate (Qmax), prostate volume, prostate-specific antigen (PSA), post-void residual urine volume (PVR), and treatment-related adverse events.
Participants received treatment for 12 weeks and were assessed at baseline and at the end of the study. Safety was evaluated by monitoring adverse events throughout the study. The findings are expected to identify the most effective and well-tolerated combination regimen for improving both urinary and sexual outcomes in men with benign prostatic hyperplasia.
- Being tested
- Tamsulosin, Tadalafil, 5-Alpha Reductase Inhibitor
- Keywords
- Benign Prostatic Hyperplasia, BPH, Lower Urinary Tract Symptoms, LUTS, Tadalafil, Tamsulosin, 5-Alpha Reductase Inhibitors, 5ARI, Finasteride, Dutasteride, Phosphodiesterase-5 Inhibitors, PDE5 Inhibitors, Erectile Function, Ejaculatory Dysfunction, IPSS, Randomized Controlled Trial, Urology
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Erectile Dysfunction, Ejaculatory Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Tamsulosin hydrochloride 0.4 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
TadalafilDrug
Tadalafil 5 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
5-Alpha Reductase InhibitorDrug
A 5-alpha reductase inhibitor (finasteride 5 mg or dutasteride 0.5 mg according to routine clinical practice) administered either once daily or every other day according to the randomized treatment allocation for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin daily + 5ARI daily | Experimental | Participants received tamsulosin 0.4 mg once daily in combination with a 5-alpha reductase inhibitor administered once daily for 12 weeks. Receives: Drug: Tamsulosin; Drug: 5-Alpha Reductase Inhibitor |
| Tamsulosin daily + 5ARI every other day | Experimental | Participants received tamsulosin 0.4 mg once daily combined with a 5-alpha reductase inhibitor administered every other day for 12 weeks. Receives: Drug: Tamsulosin; Drug: 5-Alpha Reductase Inhibitor |
| Tamsulosin every other day + 5ARI every other day | Experimental | Participants received tamsulosin 0.4 mg every other day combined with a 5-alpha reductase inhibitor administered every other day for 12 weeks. Receives: Drug: Tamsulosin; Drug: 5-Alpha Reductase Inhibitor |
| Tadalafil daily + 5ARI daily | Experimental | Participants received tadalafil 5 mg once daily in combination with a 5-alpha reductase inhibitor administered once daily for 12 weeks. Receives: Drug: Tadalafil; Drug: 5-Alpha Reductase Inhibitor |
| Tadalafil daily + 5ARI every other day | Experimental | Participants received tadalafil 5 mg once daily combined with a 5-alpha reductase inhibitor administered every other day for 12 weeks. Receives: Drug: Tadalafil; Drug: 5-Alpha Reductase Inhibitor |
| Tadalafil every other day + 5ARI every other day | Experimental | Participants received tadalafil 5 mg every other day combined with a 5-alpha reductase inhibitor administered every other day for 12 weeks. Receives: Drug: Tadalafil; Drug: 5-Alpha Reductase Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lower Urinary Tract Symptoms (IPSS)
Change in the International Prostate Symptom Score (IPSS) from baseline to Week 12. Higher scores indicate more severe symptoms; a reduction in score reflects clinical improvement.
Measured: Baseline and Week 12
Secondary outcomes (7)
Change in Erectile Function
Change in the International Index of Erectile Function-Erectile Function domain (IIEF-EF) score from baseline to Week 12. Higher scores indicate better erectile function.
Measured: Baseline and Week 12
Change in Ejaculatory Function
Change in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD) score from baseline to Week 12.
Measured: Baseline and Week 12
Change in Maximum Urinary Flow Rate (Qmax)
Change in maximum urinary flow rate measured by uroflowmetry from baseline to Week 12.
Measured: Baseline and Week 12
Change in Prostate Volume
Change in prostate volume measured by transrectal ultrasonography (TRUS) from baseline to Week 12.
Measured: Baseline and Week 12
Change in Prostate-Specific Antigen (PSA)
Change in serum prostate-specific antigen (PSA) level from baseline to Week 12.
Measured: Baseline and Week 12
Change in Post-Void Residual Volume (PVR)
Change in post-void residual urine volume measured by bladder ultrasound from baseline to Week 12.
Measured: Baseline and Week 12
Incidence of Treatment-Related Adverse Events
Frequency and type of treatment-emergent adverse events, including dizziness, orthostatic hypotension, headache, flushing, dyspepsia, gynecomastia, decreased libido, erectile dysfunction, and ejaculatory dysfunction.
Measured: Throughout the 12-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1:1:1:1:1 ratio into six parallel treatment groups to compare different dosing regimens of tadalafil or tamsulosin combined with 5-alpha reductase inhibitors. Each participant received only one assigned treatment regimen throughout the 12-week study period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Mohamed Nagy Mohamed Khalid, Beni-Suef University
- Investigators
- Omar S Taha, MBBCh, Principal investigator, Department of Urology, Faculty of Medicine, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715448
- Sponsor's protocol ID
- FMBSUREC/07092025/Taha
- Acronym
- DTT-BPH
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gacci M, Ficarra V, Sebastianelli A, Corona G, Serni S, Shariat SF, Maggi M, Zattoni F, Carini M, Novara G. Impact of medical treatments for male lower urinary tract symptoms due to benign prostatic hyperplasia on ejaculatory function: a systematic review and meta-analysis. J Sex Med. 2014 Jun;11(6):1554-66. doi: 10.1111/jsm.12525. Epub 2014 Apr 7.
PubMed 24708055Lepor H. Alpha blockers for the treatment of benign prostatic hyperplasia. Rev Urol. 2007 Fall;9(4):181-90.
PubMed 18231614Giuliano F, Uckert S, Maggi M, Birder L, Kissel J, Viktrup L. The mechanism of action of phosphodiesterase type 5 inhibitors in the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia. Eur Urol. 2013 Mar;63(3):506-16. doi: 10.1016/j.eururo.2012.09.006. Epub 2012 Sep 11.
PubMed 23018163
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effect of Different Dosing Regimens of Tadalafil or Tamsulosin Combined With 5α-Reductase Inhibitors on Urinary and Sexual Outcomes in Benign Prostatic Hyperplasia: A Comparative Clinical Trial Study"
- ClinicalTrials.gov ID
- NCT07715448
- Acronym / sponsor ID
- DTT-BPH / FMBSUREC/07092025/Taha
- Keywords
- Benign Prostatic Hyperplasia, BPH, Lower Urinary Tract Symptoms, LUTS, Tadalafil, Tamsulosin, 5-Alpha Reductase Inhibitors, 5ARI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 20 Jul 2026 (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 a common condition among aging men that causes lower urinary tract symptoms (LUTS) and may negatively affect sexual function. This randomized single-blind controlled clinical trial compares the efficacy, safety, and sexual outcomes of different dosing regimens of tadalafil or tamsulosin combined with 5-alpha reductase inhibitors (5ARIs) in men with BPH and enlarged prostate volume. A total of 240 participants were randomly assigned to six treatment groups and followed for 12 weeks. Changes in urinary symptoms, erectile function, ejaculatory function, prostate volume, prostate-specific antigen (PSA), urinary flow rate, post-void residual volume, and adverse events were evaluated to determine the optimal combination regimen.
Detailed description
Benign prostatic hyperplasia (BPH) is one of the most common causes of lower urinary tract symptoms (LUTS) in older men and is frequently associated with impaired sexual function. Alpha-blockers and 5-alpha reductase inhibitors (5ARIs) are widely used for medical management; however, both treatment strategies may adversely affect sexual function. Phosphodiesterase type-5 inhibitors, particularly tadalafil, have emerged as an alternative therapeutic option because they improve LUTS while preserving erectile function.
This randomized, single-blind, controlled clinical trial was conducted at the Department of Urology, Faculty of Medicine, Beni-Suef University, Egypt. The study enrolled 240 eligible men aged 50 years or older with moderate-to-severe LUTS secondary to BPH and prostate volume greater than 40 mL. Participants were randomly allocated into six equal treatment groups comparing different dosing regimens of tadalafil or tamsulosin combined with 5-alpha reductase inhibitors.
The primary objective was to compare improvements in lower urinary tract symptoms using the International Prostate Symptom Score (IPSS). Secondary objectives included evaluation of erectile function using the International Index of Erectile Function-Erectile Function domain (IIEF-EF), ejaculatory function using the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD), maximum urinary flow rate (Qmax), prostate volume, prostate-specific antigen (PSA), post-void residual urine volume (PVR), and treatment-related adverse events.
Participants received treatment for 12 weeks and were assessed at baseline and at the end of the study. Safety was evaluated by monitoring adverse events throughout the study. The findings are expected to identify the most effective and well-tolerated combination regimen for improving both urinary and sexual outcomes in men with benign prostatic hyperplasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- Participants were randomly assigned in a 1:1:1:1:1:1 ratio into six parallel treatment groups to compare different dosing regimens of tadalafil or tamsulosin combined with 5-alpha reductase inhibitors. Each participant received only one assigned treatment regimen throughout the 12-week study period.
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin daily + 5ARI daily | Experimental | Drug: Tamsulosin, Drug: 5-Alpha Reductase InhibitorParticipants received tamsulosin 0.4 mg once daily in combination with a 5-alpha reductase inhibitor administered once daily for 12 weeks. |
| Tamsulosin daily + 5ARI every other day | Experimental | Drug: Tamsulosin, Drug: 5-Alpha Reductase InhibitorParticipants received tamsulosin 0.4 mg once daily combined with a 5-alpha reductase inhibitor administered every other day for 12 weeks. |
| Tamsulosin every other day + 5ARI every other day | Experimental | Drug: Tamsulosin, Drug: 5-Alpha Reductase InhibitorParticipants received tamsulosin 0.4 mg every other day combined with a 5-alpha reductase inhibitor administered every other day for 12 weeks. |
| Tadalafil daily + 5ARI daily | Experimental | Drug: Tadalafil, Drug: 5-Alpha Reductase InhibitorParticipants received tadalafil 5 mg once daily in combination with a 5-alpha reductase inhibitor administered once daily for 12 weeks. |
| Tadalafil daily + 5ARI every other day | Experimental | Drug: Tadalafil, Drug: 5-Alpha Reductase InhibitorParticipants received tadalafil 5 mg once daily combined with a 5-alpha reductase inhibitor administered every other day for 12 weeks. |
| Tadalafil every other day + 5ARI every other day | Experimental | Drug: Tadalafil, Drug: 5-Alpha Reductase InhibitorParticipants received tadalafil 5 mg every other day combined with a 5-alpha reductase inhibitor administered every other day for 12 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male participants aged 50 years or older.
- Newly diagnosed with benign prostatic hyperplasia (BPH).
- Moderate to severe lower urinary tract symptoms (LUTS), defined as International Prostate Symptom Score (IPSS) > 7.
- Prostate volume >40 mL confirmed by transrectal ultrasonography (TRUS).
- Sexually active with a baseline International Index of Erectile Function-Erectile Function (IIEF-EF) score >10.
Key exclusion criteria (15 listed)
- History of prostate cancer.
- Previous prostate surgery.
- Abnormal digital rectal examination suggestive of malignancy.
- Severe erectile dysfunction (IIEF-EF score ≤10).
- Uncontrolled diabetes mellitus.
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 |
|---|---|---|
| TamsulosinTamsulosin hydrochloride 0.4 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks. | Drug | Tamsulosin daily + 5ARI daily, Tamsulosin daily + 5ARI every other day, Tamsulosin every other day + 5ARI every other day |
| TadalafilTadalafil 5 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks. | Drug | Tadalafil daily + 5ARI daily, Tadalafil daily + 5ARI every other day, Tadalafil every other day + 5ARI every other day |
| 5-Alpha Reductase InhibitorA 5-alpha reductase inhibitor (finasteride 5 mg or dutasteride 0.5 mg according to routine clinical practice) administered either once daily or every other day according to the randomized treatment allocation for 12 weeks. | Drug | Tadalafil daily + 5ARI daily, Tadalafil daily + 5ARI every other day, Tadalafil every other day + 5ARI every other day, Tamsulosin daily + 5ARI daily, Tamsulosin daily + 5ARI every other day, Tamsulosin every other day + 5ARI every other day |
Primary outcome
Change in Lower Urinary Tract Symptoms (IPSS)
Time frame: Baseline and Week 12
Change in the International Prostate Symptom Score (IPSS) from baseline to Week 12. Higher scores indicate more severe symptoms; a reduction in score reflects clinical improvement.
7 secondary outcomes
Change in Erectile Function
Time frame: Baseline and Week 12
Change in Ejaculatory Function
Time frame: Baseline and Week 12
Change in Maximum Urinary Flow Rate (Qmax)
Time frame: Baseline and Week 12
Change in Prostate Volume
Time frame: Baseline and Week 12
Change in Prostate-Specific Antigen (PSA)
Time frame: Baseline and Week 12
Change in Post-Void Residual Volume (PVR)
Time frame: Baseline and Week 12
Incidence of Treatment-Related Adverse Events
Time frame: Throughout the 12-week treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Background: PubMed 24708055Gacci M, Ficarra V, Sebastianelli A, Corona G, Serni S, Shariat SF, Maggi M, Zattoni F, Carini M, Novara G. Impact of medical treatments for male lower urinary tract symptoms due to benign prostatic hyperplasia on ejaculatory function: a systematic review and meta-analysis. J Sex Med. 2014 Jun;11(6):1554-66. doi: 10.1111/jsm.12525. Epub 2014 Apr 7.
- Background: PubMed 18231614Lepor H. Alpha blockers for the treatment of benign prostatic hyperplasia. Rev Urol. 2007 Fall;9(4):181-90.
- Background: PubMed 23018163Giuliano F, Uckert S, Maggi M, Birder L, Kissel J, Viktrup L. The mechanism of action of phosphodiesterase type 5 inhibitors in the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia. Eur Urol. 2013 Mar;63(3):506-16. doi: 10.1016/j.eururo.2012.09.006. Epub 2012 Sep 11.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Omar S Taha, MBBCh principal investigator
Department of Urology, Faculty of Medicine, Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin, Tadalafil and 5-Alpha Reductase Inhibitor in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Beni-Suef University at 1 site in Egypt.
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 7 inclusion and 15 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: finished, as of the sponsor's last update on 20 Jul 2026. 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 Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lower Urinary Tract Symptoms (IPSS) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07715448, which also lists 3 linked publications.
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 20 Jul 2026.