Prostatic NeoplasmsNCT05834270
Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe LUTS Due to BPH
A study testing Single dose tamsulosin 0.4mg and Double dose tamsulosin 0.4mg in people with Prostatic Neoplasms and Prostate Disease, run by Menoufia University at 1 site in Egypt.
Trial summary
Single dose versus double dose tamsulosin in Management of Moderate and severe lower urinary tract symptoms due to benign prostatic hyperplasia Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostatic Neoplasms, Prostate Disease, Prostate Obstruction
- What is being tested?
- Single dose tamsulosin 0.4mg and Double dose tamsulosin 0.4mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Dec 2022
- Phase
- Interventional
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age more than 50 years
- moderate to severe lower urinary tract symptoms
Who cannot join
- prostatic cancer
- urethral stricture
- prostate surgery
- Neurogenic bladder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Single dose versus double dose tamsulosin in Management of Moderate and severe lower urinary tract symptoms due to benign prostatic hyperplasia
- Being tested
- Single dose tamsulosin 0.4mg, Double dose tamsulosin 0.4mg
- Keywords
- Tamsulosin, Prostate
- Medical subject headings
- Prostatic Neoplasms, Prostatic Diseases, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose tamsulosin 0.4mgDrug
Single dose tamsulosin 0.4mg
Double dose tamsulosin 0.4mgDrug
Double dose tamsulosin 0.4mg
| Study group | Role | What they receive |
|---|---|---|
| Single dose tamsulosin 0.4mg | Active comparator | Single dose tamsulosin 0.4mg Receives: Drug: Single dose tamsulosin 0.4mg |
| Double dose tamsulosin 0.4mg | Active comparator | Double dose tamsulosin 0.4mg Receives: Drug: Double dose tamsulosin 0.4mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the lower urinary tract symptoms
Assessed by the improvement in the internal prostatic symptoms score (IPSS)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 May 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Menoufia 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M. Hassan, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834270
- Sponsor's protocol ID
- SD vs DD Tamsulosin
- Status last verified
- Apr 2023
- First submitted
- 17 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT05834270
- Acronym / sponsor ID
- SD vs DD Tamsulosin
- Keywords
- Tamsulosin, Prostate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 28 Apr 2023 (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.
Single dose versus double dose tamsulosin in Management of Moderate and severe lower urinary tract symptoms due to benign prostatic hyperplasia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single dose tamsulosin 0.4mg | Active comparator | Drug: Single dose tamsulosin 0.4mgSingle dose tamsulosin 0.4mg |
| Double dose tamsulosin 0.4mg | Active comparator | Drug: Double dose tamsulosin 0.4mgDouble dose tamsulosin 0.4mg |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age more than 50 years
- moderate to severe lower urinary tract symptoms
Key exclusion criteria (4 listed)
- prostatic cancer
- urethral stricture
- prostate surgery
- Neurogenic bladder
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 |
|---|---|---|
| Single dose tamsulosin 0.4mgSingle dose tamsulosin 0.4mg | Drug | Single dose tamsulosin 0.4mg |
| Double dose tamsulosin 0.4mgDouble dose tamsulosin 0.4mg | Drug | Double dose tamsulosin 0.4mg |
Primary outcome
Change in the lower urinary tract symptoms
Time frame: 3 months
Assessed by the improvement in the internal prostatic symptoms score (IPSS)
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 28 Apr 2023.
- 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.
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 study testing Single dose tamsulosin 0.4mg and Double dose tamsulosin 0.4mg in people with Prostatic Neoplasms and Prostate Disease, run by Menoufia 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 2 inclusion and 4 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 28 Apr 2023. 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.
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 the lower urinary tract symptoms (time frame: 3 months). 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 28 Apr 2023.