Prostate Cancer With Radical Prostatectomy Clinical Trial
— DA8159_EDP_IITOfficial 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
This study evaluates the efficacy and safety of Udenafil dosed once a day in patients with erectile dysfunction after bilateral nerve-sparing radical prostatectomy.
| Status | Not yet recruiting |
| Enrollment | 99 |
| Est. completion date | December 2019 |
| Est. primary completion date | May 2019 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 20 Years to 70 Years |
| Eligibility |
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 (5a-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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Samsung Medical Center | Dong-A ST Co., Ltd. |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Safety evaulation: Occurrence of any adverse events | The AE is evaluated for grade, intensity, relationship by protocol definition | for 32 weeks | |
| Secondary | Safety evaluation: Systolic and diastolic blood pressure | by Physical exam, mmHg | for 32 weeks | |
| Secondary | Safety evaluation: 12-lead ECG | ECG test | for 32 weeks | |
| Secondary | Safety evaluation: Number of Participants With Abnormal Laboratory Values | Blood and urine test | for 32 weeks | |
| Secondary | Safety evaluation:pulse rate | by Physical exam, beats per minute | for 32 weeks |