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

May 4, 2017 updated by: Seong Soo Jeon, Samsung Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at 32 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety evaulation: Occurrence of any adverse events
Time Frame: for 32 weeks
The AE is evaluated for grade, intensity, relationship by protocol definition
for 32 weeks
Safety evaluation: Systolic and diastolic blood pressure
Time Frame: for 32 weeks
by Physical exam, mmHg
for 32 weeks
Safety evaluation: 12-lead ECG
Time Frame: for 32 weeks
ECG test
for 32 weeks
Safety evaluation: Number of Participants With Abnormal Laboratory Values
Time Frame: for 32 weeks
Blood and urine test
for 32 weeks
Safety evaluation:pulse rate
Time Frame: for 32 weeks
by Physical exam, beats per minute
for 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dong-A ST Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SeongSoo Jeon, PhD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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