The Efficacy and Safety of Udenafil in Patients With Erectile Dysfunction After Bilateral Nerve-sparing Radical Prostatectomy

NCT ID: NCT03142542

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2019-12-31

Brief 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.

Conditions

Prostate Cancer With Radical Prostatectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Udenafil 75mg

Drug: Udenafil 75mg by mouth, once daily, for 32 weeks

Group Type: EXPERIMENTAL

ZYDENA TAB.75mg(Udenafil 75mg)

Intervention Type: DRUG

ZYDENA TAB.75mg(Udenafil 75mg): by mouth, Once daily, for 32 weeks

Placebo

Drug: placebo by mouth, once daily, for 32 weeks

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Placebo Oral Tablet: by mouth, Once daily, for 32 weeks

Interventions

ZYDENA TAB.75mg(Udenafil 75mg)

ZYDENA TAB.75mg(Udenafil 75mg): by mouth, Once daily, for 32 weeks

Intervention Type: DRUG

Placebo Oral Tablet

Placebo Oral Tablet: by mouth, Once daily, for 32 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Seong Soo Jeon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SeongSoo Jeon, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Central Contacts

SeongSoo Jeon, PhD

Role: CONTACT

seongsoo.jeon@samsung.com

82-2-3410-3555

HongMo An, Master

Role: CONTACT

ahm0125.an@samsung.com

82-2-3410-6853

Other Identifiers

2017-02-112

Identifier Type: -

Identifier Source: org_study_id