Benign Prostatic HyperplasiaPhase 3NCT02862483
The Efficacy and Safety of the Combination of Tamsulosin and Tadalafil in Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia and Erectile Dysfunction
A Phase 3 study testing Tamsulosin 0.2mg and Tadalafil 5mg in people with Benign Prostatic Hyperplasia and Erectile Dysfunction, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial summary
The efficacy and safety of the combination of tamsulosin and tadalafil in men with lower urinary tract symptoms due to benign prostatic hyperplasia and Erectile Dysfunction: a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Erectile Dysfunction
- What is being tested?
- Tamsulosin 0.2mg and Tadalafil 5mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Mar 2017
- 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
- Visit1
- Male aged 45 years old or older
- Subjects who have PSA ≤ 4.0 ng/mL Visit2
- Subjects who have Total IPSS score ≥ 13
- Subjects who have IIEF-EF domain ≤ 24 and each point below 3 in question 3 and 4
Who cannot join
- Subjects who have hypersensitivity to investigational product or sulfa medications
Trial locations and contacts
1 site in 1 country.
Ji-yoon Choi contact
South Korea1 site, 1 recruiting
- Recruiting
Catholic university of korea, Seoul ST. Mary's Hospital.
Seoul
Sae Woong Kim
About this study
The efficacy and safety of the combination of tamsulosin and tadalafil in men with lower urinary tract symptoms due to benign prostatic hyperplasia and Erectile Dysfunction: a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial
- Conditions
- Benign Prostatic Hyperplasia, Erectile Dysfunction
- Being tested
- Tamsulosin 0.2mg, Tadalafil 5mg, Placebo for Tamsulosin
- Medical subject headings
- Prostatic Hyperplasia, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin 0.2mgDrug
Tadalafil 5mgDrug
Placebo for TamsulosinDrug
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Tamsulosin 0.2mg and Tadalafil 5mg Receives: Drug: Tamsulosin 0.2mg; Drug: Tadalafil 5mg |
| Comparator | Active comparator | placebo for Tamsulosin 0.2mg and Tadalafil 5mg Receives: Drug: Tadalafil 5mg; Drug: Placebo for Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of total IPSS(International prostate symptom score)
Measured: From baseline at week 12
The change of IIEF-EF(International Index of Erectile Function sum of questions-Erectile function) domain
Measured: From baseline at week 12
Secondary outcomes (15)
The change of total IPSS(International prostate symptom score)
Measured: From baseline at week 4,8
The change of total IPSS(International prostate symptom score) sub score (storage, voiding)
Measured: From baseline at week 4,8 and 12
The change of IPSS(International prostate symptom score) QoL(Quality of Life)
Measured: From baseline at week 4,8 and 12
The change of Qmax(maximum urinary flow rate)
Measured: From baseline at week 4,8 and 12
The change of PVR(Post Void Residual Volume)
Measured: From baseline at week 4,8 and 12
PGIC(Patient Global Impression of change) score
Measured: At week 12
CGIC(Clinician Global Impression of change) score
Measured: At week 12
The change of IIEF (International Index of Erectile Function sum of questions) total score
Measured: From baseline at week 4,8 and 12
The change of IIEF-IS(International Index of Erectile Function sum of questions-Intercourse satisfaction) domain score measured by IIEF question number 6~8
Measured: From baseline at week 4,8 and 12
The change of OS(Overall satisfaction) domain score measured by IIEF question number13 and 14
Measured: From baseline at week 4,8 and 12
The change of OF(Orgasmic function) domain score measured by IIEF question number 9 and 10)
Measured: From baseline at week 4,8 and 12
The change of IIEF-EF domain(International Index of Erectile Function sum of questions-Erectile function) score measured by IIEF question number 1~5 and 15
Measured: From baseline at week 4,8
The change of IIEF(International Index of Erectile Function) score about questions number 3 and 4
Measured: From baseline at week 12
The percentage of patients who have more than 4 point about IIEF questions number 3 and 4
Measured: From baseline at week 12
The percentage of patients who have increased score about IIEF questions number 3 and 4(at least 1 point) compared to the baseline
Measured: From baseline at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862483
- Sponsor's protocol ID
- ID-TATA-301
- Status last verified
- Aug 2016
- First submitted
- 22 Jul 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of the Combination of Tamsulosin and Tadalafil in Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia and Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT02862483
- Acronym / sponsor ID
- ID-TATA-301
- Conditions
- Benign Prostatic Hyperplasia, Erectile Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 11 Aug 2016 (estimated)
- 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 efficacy and safety of the combination of tamsulosin and tadalafil in men with lower urinary tract symptoms due to benign prostatic hyperplasia and Erectile Dysfunction: a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Tamsulosin 0.2mg, Drug: Tadalafil 5mgTamsulosin 0.2mg and Tadalafil 5mg |
| Comparator | Active comparator | Drug: Tadalafil 5mg, Drug: Placebo for Tamsulosinplacebo for Tamsulosin 0.2mg and Tadalafil 5mg |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Visit1
- Male aged 45 years old or older
- Subjects who have PSA ≤ 4.0 ng/mL Visit2
- Subjects who have Total IPSS score ≥ 13
- Subjects who have IIEF-EF domain ≤ 24 and each point below 3 in question 3 and 4
Key exclusion criteria (1 listed)
- Subjects who have hypersensitivity to investigational product or sulfa medications
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 |
|---|---|---|
| Tamsulosin 0.2mg | Drug | Experimental |
| Tadalafil 5mg | Drug | Comparator, Experimental |
| Placebo for Tamsulosin | Drug | Comparator |
Primary outcome
The change of total IPSS(International prostate symptom score)
Time frame: From baseline at week 12
The change of IIEF-EF(International Index of Erectile Function sum of questions-Erectile function) domain
Time frame: From baseline at week 12
15 secondary outcomes
The change of total IPSS(International prostate symptom score)
Time frame: From baseline at week 4,8
The change of total IPSS(International prostate symptom score) sub score (storage, voiding)
Time frame: From baseline at week 4,8 and 12
The change of IPSS(International prostate symptom score) QoL(Quality of Life)
Time frame: From baseline at week 4,8 and 12
The change of Qmax(maximum urinary flow rate)
Time frame: From baseline at week 4,8 and 12
The change of PVR(Post Void Residual Volume)
Time frame: From baseline at week 4,8 and 12
PGIC(Patient Global Impression of change) score
Time frame: At week 12
CGIC(Clinician Global Impression of change) score
Time frame: At week 12
The change of IIEF (International Index of Erectile Function sum of questions) total score
Time frame: From baseline at week 4,8 and 12
The change of IIEF-IS(International Index of Erectile Function sum of questions-Intercourse satisfaction) domain score measured by IIEF question number 6~8
Time frame: From baseline at week 4,8 and 12
The change of OS(Overall satisfaction) domain score measured by IIEF question number13 and 14
Time frame: From baseline at week 4,8 and 12
The change of OF(Orgasmic function) domain score measured by IIEF question number 9 and 10)
Time frame: From baseline at week 4,8 and 12
The change of IIEF-EF domain(International Index of Erectile Function sum of questions-Erectile function) score measured by IIEF question number 1~5 and 15
Time frame: From baseline at week 4,8
The change of IIEF(International Index of Erectile Function) score about questions number 3 and 4
Time frame: From baseline at week 12
The percentage of patients who have more than 4 point about IIEF questions number 3 and 4
Time frame: From baseline at week 12
The percentage of patients who have increased score about IIEF questions number 3 and 4(at least 1 point) compared to the baseline
Time frame: From baseline at week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- 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.
Ji-yoon Choi contact
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 Tamsulosin 0.2mg and Tadalafil 5mg in people with Benign Prostatic Hyperplasia and Erectile Dysfunction, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
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 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: status not confirmed, as of the sponsor's last update on 12 Aug 2016. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji-yoon Choi (jychoi@ildong.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of total IPSS(International prostate symptom score) (time frame: From baseline at week 12). 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 12 Aug 2016.