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Trial record 32 of 53 for:    Recruiting, Not yet recruiting, Available Studies | "Impotence"

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

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ClinicalTrials.gov Identifier: NCT03142542
Recruitment Status : Not yet recruiting
First Posted : May 5, 2017
Last Update Posted : May 5, 2017
Sponsor:
Collaborator:
Dong-A ST Co., Ltd.
Information provided by (Responsible Party):
Seong Soo Jeon, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer With Radical Prostatectomy Drug: ZYDENA TAB.75mg(Udenafil 75mg) Drug: Placebo Oral Tablet Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: placebo-controlled
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
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
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Safety evaulation: Occurrence of any adverse events [ Time Frame: for 32 weeks ]
    The AE is evaluated for grade, intensity, relationship by protocol definition

  2. Safety evaluation: Systolic and diastolic blood pressure [ Time Frame: for 32 weeks ]
    by Physical exam, mmHg

  3. Safety evaluation: 12-lead ECG [ Time Frame: for 32 weeks ]
    ECG test

  4. Safety evaluation: Number of Participants With Abnormal Laboratory Values [ Time Frame: for 32 weeks ]
    Blood and urine test

  5. Safety evaluation:pulse rate [ Time Frame: for 32 weeks ]
    by Physical exam, beats per minute



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142542


Contacts
Contact: SeongSoo Jeon, PhD 82-2-3410-3555 seongsoo.jeon@samsung.com
Contact: HongMo An, Master 82-2-3410-6853 ahm0125.an@samsung.com

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

Responsible Party: Seong Soo Jeon, Principal Investigator, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03142542     History of Changes
Other Study ID Numbers: 2017-02-112
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Udenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action