BPH With Other Lower Urinary Tract SymptomsPhase 3NCT06466369
Administration of Tadalafil in Patients With Benign Prostatic Hyperplasia
A Phase 3 study testing Tadalafil in people with BPH With Other Lower Urinary Tract Symptoms, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of the present study is to evaluate the efficacy and safety of once daily administration PDE5 inhibitors, tadalafil for 3 months as anti-inflammatory, antiproliferative and relaxant effects in ED with BPH patients. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- BPH With Other Lower Urinary Tract Symptoms
- What is being tested?
- Tadalafil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2024to 1 Aug 2024
- Phase
- Phase 3
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 45 years and sexually active with symptomatic benign prostatic hyperplasia (no hospitalization 3 months prior to start of treatment).
Who cannot join
- 1. Patients with bladder or prostate malignancy. 2. A history of lower urinary tract surgery. 3. History of catheterization. 4. Urinary retention. 5. Urinary tract infection. 6. Stone disease. 7. Any neurological disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
outpatient clinic of the urology department at AlZahraa University Hospital, Al-Azhar University, Faculty of Medicine for Girls.
Cairo
About this study
Official title: Efficacy and Safety of Once Daily Administration Tadalafil in Patients With Benign Prostatic Hyperplasia
The aim of the present study is to evaluate the efficacy and safety of once daily administration PDE5 inhibitors, tadalafil for 3 months as anti-inflammatory, antiproliferative and relaxant effects in ED with BPH patients.
- Being tested
- Tadalafil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TadalafilDrug
tadalafil 2.5 mg, 5 mg
| Study group | Role | What they receive |
|---|---|---|
| Controlled group | No intervention | Not described |
| Low-dose intervention group | Experimental | Not described Receives: Drug: Tadalafil |
| High-dose intervention group | Experimental | Not described Receives: Drug: Tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of International prostate symptom score (IPSS)/quality of life (QoL).
Measured: 3 months compared to baseline
Evaluation of International index of erectile function (IIEF).
Measured: 3 months compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start15 Mar 2024
- Primary completion1 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH With Other Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel, double-blinded, prospective, randomized controlled study.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed salah saad abomandour, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466369
- Sponsor's protocol ID
- 461
- Status last verified
- Aug 2024
- First submitted
- 14 Jun 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Once Daily Administration Tadalafil in Patients With Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT06466369
- Acronym / sponsor ID
- 461
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 20 Jun 2024 (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.
The aim of the present study is to evaluate the efficacy and safety of once daily administration PDE5 inhibitors, tadalafil for 3 months as anti-inflammatory, antiproliferative and relaxant effects in ED with BPH patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Parallel, double-blinded, prospective, randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Controlled group | No intervention | – |
| Low-dose intervention group | Experimental | Drug: Tadalafil |
| High-dose intervention group | Experimental | Drug: Tadalafil |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged ≥ 45 years and sexually active with symptomatic benign prostatic hyperplasia (no hospitalization 3 months prior to start of treatment).
Key exclusion criteria (1 listed)
- 1. Patients with bladder or prostate malignancy. 2. A history of lower urinary tract surgery. 3. History of catheterization. 4. Urinary retention. 5. Urinary tract infection. 6. Stone disease. 7. Any neurological disease.
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 |
|---|---|---|
| Tadalafiltadalafil 2.5 mg, 5 mg | Drug | High-dose intervention group, Low-dose intervention group |
Primary outcome
Evaluation of International prostate symptom score (IPSS)/quality of life (QoL).
Time frame: 3 months compared to baseline
Evaluation of International index of erectile function (IIEF).
Time frame: 3 months compared to baseline
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 23 Aug 2024.
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WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80 - 180mL) in Benign Prostatic Hyperplasia
BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
RecruitingPhase 4
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tadalafil in people with BPH With Other Lower Urinary Tract Symptoms, run by Al-Azhar 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 1 inclusion and 1 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 23 Aug 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Evaluation of International prostate symptom score (IPSS)/quality of life (QoL). (time frame: 3 months compared to baseline). The study lists 2 primary outcomes in all. 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 23 Aug 2024.