Prostate Cancer With Radical ProstatectomyPhase 4DA8159_EDP_IITNCT03142542
The Efficacy and Safety of Udenafil in Patients With Erectile Dysfunction After Bilateral Nerve-sparing Radical Prostatectomy
A Phase 4 study testing ZYDENA TAB.75mg(Udenafil 75mg) in people with Prostate Cancer With Radical Prostatectomy, run by Samsung Medical Center.
Trial summary
This study evaluates the efficacy and safety of Udenafil dosed once a day in patients with erectile dysfunction after bilateral nerve-sparing radical prostatectomy. Read more about this study
- Who is it for?
- Ages 20 to 70 years, men only
- Conditions the study is for
- Prostate Cancer With Radical Prostatectomy
- What is being tested?
- ZYDENA TAB.75mg(Udenafil 75mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- May 2017to Dec 2019
- 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 20 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male aged 20 or over 20 years and not more than 70 years who underwent bilateral nerve-sparing radical prostatectomy due to prostate cancer without metastasis
- IIEF-EF score ≥22 at 1-8 weeks before bilateral nerve-sparing radical prostatectomy, and IIEF-EF ≤16 at screening visit
- Presence of sexual partner from 8 weeks before bilateral nerve-sparing radical prostatectomy, and had planned to keep it during the trial
- Agreed not to use any other erectile dysfunction medication (including both generic and specialty medicines) and other erectile dysfunction therapies during the trial period.
- Patient agrees to voluntary participation and follow the instructions carefully, after fully hearing and understanding the details of this clinical trial
Who cannot join
- Patient who needs additional treatment in addition to bilateral nerve- sparing radical prostatectomy
- Use Inhibitors of PDE-5 (Viagra®, Levitra®, Cialis®, Zydena®, Yaila®, Mvix® and Generic Medicines) or autologous injections of vasodilators or other erectile dysfunction therapies for erectile dysfunction within the first 8 weeks of bilateral nerve-sparing radical prostatectomy
- If there is an uncontrolled diabetes (HbA1C> 12%) at Visit 1
- If there is proliferative diabetic retinopathy at Visit 1
- If there is a history of CABG surgery, stroke, unstable angina, myocardial infarction, life-threatening arrhythmia, or heart failure within 6 months before the screening visit
- History of spinal cord injury, non nerve-sparing radical prostatectomy or radical pelvic surgery
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- Hypotension below 90 / 50mmHg or uncontrolled hypertension above 170 / 100mmHg
- Penis anatomic abnormalities (severe penile fibrosis, Peyronie's disease, etc.)
- Presence of serious disability such as malignant tumor, lung, blood, endocrine system in Visit 1
- Patient who have active hepatitis B or C or who are infected with HIV virus
- Patient who have genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency, glucose-galactose uptake disorder
- Patient who have hyperprolactinemia or hypothyroidism
- Serum AST and ALT are three times higher than normal upper limit
- Serum Creatinine ≥ 2.5 mg / dl
- Patient who have retinitis pigmentosa
- Patient who have blood disease (sickle cell disease, multiple myeloma, leukemia) or bleeding disorder that can cause priapism
- Patient with congenital QT prolongation syndrome or those taking a drug that increases QT interval
- If the examiner considers that he / she is not suitable for participation in clinical trials, such as mental disorder or persistent abuse of medication
- Patient who is taking Nitrate / Nitric oxide (NO) donor (Nitroglycerin, Sodium nitroprusside, Isosorbide mononitrate / dinitrate, Amyl nitrate / nitrite, etc.)
- Patient who is taking Guanylate Cyclase stimulator (such as Riociguat)
- Patient who is taking warfarin
- Patient who is taking medications or foods that affect CYP3A4 metabolism
- Metabolic inhibitors: Antibacterials (Erythromycin, etc.), Antifungals (Itraconazole, etc.), Antivirals (Ritonavir, Saquinavir, Amprenavir, Indinavir, Nelfinavir, etc.), H2 receptor antagonist (Cimetidine, etc), or grapefruit juice
- Metabolic inducers: Dexamethasone, Rifampicin, Antipyretics (Phenytoin, Phenobarbital, Carbamazepine, etc.)
- Patient who is taking androgens (Testosterone, etc.) or anti-androgens (5α-reductase inhibitors such as Finasteride, Dutasteride and anti- androgen hormones such as Flutamide and Bicalutamide)
- Patient who is taking Trazodone
- Patient who received other clinical trial medications (including placebo) within 4 weeks before the screening visit
- History of hypersensitivity reactions to PDE-5 inhibitors (Viagra®, Levitra®, Cialis®, Zydena®, Yaila®, Mvix® and each Generic drug)
- Patient who did not respond to PDE-5 inhibitors (Viagra®, Levitra®, Cialis®, Zydena®, Yaila®, Mvix® and each Generic drug)
- Patient who has hypoactive sexual desire
- If the examiner judges that it is not suitable for participation in this trial
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Investigator Initiated Clinical Trial to Evaluate the Efficacy and Safety of Udenafil Dosed Once a Day in Patients With Erectile Dysfunction After Bilateral Nerve-sparing Radical Prostatectomy
This study evaluates the efficacy and safety of Udenafil dosed once a day in patients with erectile dysfunction after bilateral nerve-sparing radical prostatectomy.
- Being tested
- ZYDENA TAB.75mg(Udenafil 75mg), Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZYDENA TAB.75mg(Udenafil 75mg)Drug
ZYDENA TAB.75mg(Udenafil 75mg): by mouth, Once daily, for 32 weeks
Placebo Oral TabletDrug
Placebo Oral Tablet: by mouth, Once daily, for 32 weeks
| Study group | Role | What they receive |
|---|---|---|
| Udenafil 75mg | Experimental | Drug: Udenafil 75mg by mouth, once daily, for 32 weeks Receives: Drug: ZYDENA TAB.75mg(Udenafil 75mg) |
| Placebo | Placebo comparator | Drug: placebo by mouth, once daily, for 32 weeks Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who has IIEF-EF score ≥22
The IIEF-EF score is International Index of Erectile Function - Erectile Function. The Questionaire is composed of 6 questions.
Measured: at 32 weeks
Secondary outcomes (5)
Safety evaulation: Occurrence of any adverse events
The AE is evaluated for grade, intensity, relationship by protocol definition
Measured: for 32 weeks
Safety evaluation: Systolic and diastolic blood pressure
by Physical exam, mmHg
Measured: for 32 weeks
Safety evaluation: 12-lead ECG
ECG test
Measured: for 32 weeks
Safety evaluation: Number of Participants With Abnormal Laboratory Values
Blood and urine test
Measured: for 32 weeks
Safety evaluation:pulse rate
by Physical exam, beats per minute
Measured: for 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study startMay 2017 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer With Radical ProstatectomyStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Responsible party
- Principal investigator, Seong Soo Jeon, Samsung Medical Center
- Investigators
- SeongSoo Jeon, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142542
- Sponsor's protocol ID
- 2017-02-112
- Acronym
- DA8159_EDP_IIT
- Status last verified
- May 2017
- First submitted
- 11 Apr 2017
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Investigator Initiated Clinical Trial to Evaluate the Efficacy and Safety of Udenafil Dosed Once a Day in Patients With Erectile Dysfunction After Bilateral Nerve-sparing Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT03142542
- Acronym / sponsor ID
- DA8159_EDP_IIT / 2017-02-112
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Study start
- May 2017 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 May 2017 (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.
This study evaluates the efficacy and safety of Udenafil dosed once a day in patients with erectile dysfunction after bilateral nerve-sparing radical prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Udenafil 75mg | Experimental | Drug: ZYDENA TAB.75mg(Udenafil 75mg)Drug: Udenafil 75mg by mouth, once daily, for 32 weeks |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletDrug: placebo by mouth, once daily, for 32 weeks |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male aged 20 or over 20 years and not more than 70 years who underwent bilateral nerve-sparing radical prostatectomy due to prostate cancer without metastasis
- IIEF-EF score ≥22 at 1-8 weeks before bilateral nerve-sparing radical prostatectomy, and IIEF-EF ≤16 at screening visit
- Presence of sexual partner from 8 weeks before bilateral nerve-sparing radical prostatectomy, and had planned to keep it during the trial
- Agreed not to use any other erectile dysfunction medication (including both generic and specialty medicines) and other erectile dysfunction therapies during the trial period.
- Patient agrees to voluntary participation and follow the instructions carefully, after fully hearing and understanding the details of this clinical trial
Key exclusion criteria (31 listed)
- Patient who needs additional treatment in addition to bilateral nerve- sparing radical prostatectomy
- Use Inhibitors of PDE-5 (Viagra®, Levitra®, Cialis®, Zydena®, Yaila®, Mvix® and Generic Medicines) or autologous injections of vasodilators or other erectile dysfunction therapies for erectile dysfunction within the first 8 weeks of bilateral nerve-sparing radical prostatectomy
- If there is an uncontrolled diabetes (HbA1C> 12%) at Visit 1
- If there is proliferative diabetic retinopathy at Visit 1
- If there is a history of CABG surgery, stroke, unstable angina, myocardial infarction, life-threatening arrhythmia, or heart failure within 6 months before the screening visit
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 |
|---|---|---|
| ZYDENA TAB.75mg(Udenafil 75mg)ZYDENA TAB.75mg(Udenafil 75mg): by mouth, Once daily, for 32 weeks | Drug | Udenafil 75mg |
| Placebo Oral TabletPlacebo Oral Tablet: by mouth, Once daily, for 32 weeks | Drug | Placebo |
Primary outcome
The proportion of patients who has IIEF-EF score ≥22
Time frame: at 32 weeks
The IIEF-EF score is International Index of Erectile Function - Erectile Function. The Questionaire is composed of 6 questions.
5 secondary outcomes
Safety evaulation: Occurrence of any adverse events
Time frame: for 32 weeks
Safety evaluation: Systolic and diastolic blood pressure
Time frame: for 32 weeks
Safety evaluation: 12-lead ECG
Time frame: for 32 weeks
Safety evaluation: Number of Participants With Abnormal Laboratory Values
Time frame: for 32 weeks
Safety evaluation:pulse rate
Time frame: for 32 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
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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.
SeongSoo Jeon, PhD principal investigator
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ZYDENA TAB.75mg(Udenafil 75mg) in people with Prostate Cancer With Radical Prostatectomy, run by Samsung Medical Center.
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 31 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 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SeongSoo Jeon, PhD (82-2-3410-3555, seongsoo.jeon@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who has IIEF-EF score ≥22 (time frame: at 32 weeks). 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 5 May 2017.