Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
104 participants
INTERVENTIONAL
2011-11-30
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A
YHD1023
5g oral once daily
Group B
YHD1023
5g oral twice a day
Group C
YHD1023
10g oral once daily
Group D
Cialis
5mg oral once daily
Group E
Placebo
Oral
Interventions
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YHD1023
5g oral once daily
YHD1023
5g oral twice a day
YHD1023
10g oral once daily
Cialis
5mg oral once daily
Placebo
Oral
Eligibility Criteria
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Inclusion Criteria
* Anticipate having the same adult female sexual partner, who have no possibility of being pregnant or breast-feeding and take steps to prevent conception during the study
* The patient or legally authorized representative must sign a written informed consent, prior to the any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
* Have Erectile Function(EF) domain score 25 and under as the result of the International Index of Erectile Function(IIEF)
* Agree to make at least 4 sexual intercourse attempts on 4 separate days with the female sexual study party during the 4-week run-in period without medication and at least 50% of attempts during this period had been unsuccessful due to insufficient erection or unable to sustain penile rigidity until ejaculation
Exclusion Criteria
* Have history of cardiac failure, unstable angina, or life-threatening arrhythmia within the last 6 months
* Shown tachyarrhythmia, heart rate over 100 times/min(e.g. arterial fibrillation, flutter)
* Presence of hypotension as evidenced by SBP/DBP \< 90/50mmHg or uncontrollable hypertension as evidenced by SBP/DBP \> 170/100mmHg
* Presence of diagnosed diabetes(HbA1C \> 12%)
* Have history of symptomatic postural hypotension within the last 6 months
* Have history of spinal cord injury, radical prostatectomy, or pelvic surgery
* Presence of penile anatomical deformities (e.g. severe penile fibrosis or Peyronie's disease)
* Presence of hypogonadism(serum total testosterone under the reference lowest limit)
* Presence of hepatic impairment(AST or ALT \> 3 times of normal upper limit) or renal impairment(serum creatinine ≥ 2.5mg/dl)
* Have history of severe gastrointestinal hemorrhage within the last 1 year
* Have history of hematodyscrasia predisposing to priapism(e.g. sickle cell disease, multiple myeloma, or leukemia) or bleeding disorder
* Subject who is judged to be ineligible according to their physical checkup(medical history, physical examination, ECG, laboratory values and etc.) within 56 days prior to the first administration
* Concomitant use of one or more of nitrates/nitric oxide(NO) donor(e.g. nitroglycerine, isosorbid, mononitrate, isosorbid dinitrate, amylnitrate/nitrite, sodium nitroprusside), Trazodone, cancer chemotherapy, anticoagulants, androgens, or anti-androgens
* Use of any PDE-5 inhibitor(e.g. Viagra, Levitra, Cialis, Yaila, or Zydena), vasodilator self-injection, or other treatments for erectile dysfunction within the last 2 weeks prior to the study
* Participated in any other clinical trials within 30 days prior to the first administration
* Have history of primary hypoactive sexual desire
* Subject who is judged to be ineligible by principal investigator or sub-investigator due to mental disorder or continuous drug abuse
20 Years
MALE
No
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Nam-Cheol Park, MD, PhD.
Role: PRINCIPAL_INVESTIGATOR
Busan National University Hospital
Locations
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Yuhan Corporation
Seoul, , South Korea
Countries
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Other Identifiers
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YHD1023-201
Identifier Type: -
Identifier Source: org_study_id