The Efficacy and Safety of Udenafil in Patients With Erectile Dysfunction After Bilateral Nerve-sparing Radical Prostatectomy (DA8159_EDP_IIT)

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer With Radical Prostatectomy
• Intervention / Treatment: Drug: ZYDENA TAB.75mg(Udenafil 75mg); Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 99
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Udenafil 75mg; Drug: Udenafil 75mg by mouth, once daily, for 32 weeks	Drug: ZYDENA TAB.75mg(Udenafil 75mg); ZYDENA TAB.75mg(Udenafil 75mg): by mouth, Once daily, for 32 weeks
Placebo Comparator: Placebo; Drug: placebo by mouth, once daily, for 32 weeks	Drug: Placebo Oral Tablet; Placebo Oral Tablet: by mouth, Once daily, for 32 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 32 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaulation: Occurrence of any adverse events	The AE is evaluated for grade, intensity, relationship by protocol definition	for 32 weeks
Safety evaluation: Systolic and diastolic blood pressure	by Physical exam, mmHg	for 32 weeks
Safety evaluation: 12-lead ECG	ECG test	for 32 weeks
Safety evaluation: Number of Participants With Abnormal Laboratory Values	Blood and urine test	for 32 weeks
Safety evaluation:pulse rate	by Physical exam, beats per minute	for 32 weeks

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Dong-A ST Co., Ltd.
• Investigators: Principal Investigator: SeongSoo Jeon, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2017
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Udenafil
• Other Study ID Numbers: 2017-02-112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No