Phase II clinical trial to Assess the Safety and Efficacy of YHD1023 in Patients with Erectile Dysfunctio
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0001049
- Lead Sponsor
- Yuhan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 112
Male volunteers of aged 20 years and older with history of organic erectile dysfunction of at least 6 months duration
- 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 history of stroke, myocardial infarction, or Coronary Artery Bypass Graft surgery within the last 6 months
- 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
- Have history of symptomatic postural hypotension within the last 6 months
- Have history of spinal cord injury, radical prostatectomy, or pelvic surgery
- 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
- Participated in any other clinical trials within 30 days prior to the first administration
- Subject who is judged to be ineligible by principal investigator or sub-investigator due to mental disorder or continuous drug abuse
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in the International Index of Erectile Function(IIEF) - Erectile Function(EF) domain score at week 8
- Secondary Outcome Measures
Name Time Method Mean change from baseline in other Question of International Index of Erectile Function(IIEF) domain at week 8 ;Percentage of Improved patients from baseline in Question 2 & Question 3 of Sexual Encounter Profile(SEP) at week 8