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

NCT03142542 | Unknown Phase 4

• 1 other identifier: 2017-02-112
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Safety evaulation: Occurrence of any adverse events

  for 32 weeks

• Safety evaluation: Systolic and diastolic blood pressure

  for 32 weeks

• Safety evaluation: 12-lead ECG

  for 32 weeks

• Safety evaluation: Number of Participants With Abnormal Laboratory Values

  for 32 weeks

• Safety evaluation:pulse rate

  for 32 weeks

Study Arms (2)

Udenafil 75mg

EXPERIMENTAL

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

Drug: ZYDENA TAB.75mg(Udenafil 75mg)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

ZYDENA TAB.75mg(Udenafil 75mg) DRUG

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

Udenafil 75mg

Placebo Oral Tablet DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Dong-A ST Co., Ltd.: collaborator

Study Officials

• SeongSoo Jeon, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SeongSoo Jeon, PhD

CONTACT

82-2-3410-3555; seongsoo.jeon@samsung.com

HongMo An, Master

CONTACT

82-2-3410-6853; ahm0125.an@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: placebo-controlled

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: May 5, 2017
• Study Start: May 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 5, 2017

Record last verified: 2017-05