Status:
UNKNOWN
Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 in Male Patients With Premature Ejaculation
Lead Sponsor:
Dong-A Pharmaceutical Co., Ltd.
Conditions:
Premature Ejaculation
Eligibility:
MALE
20-64 years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate the efficacy and safety of DA-8031 and to decide the optimal dose of DA-8031 in male patients with premature ejaculation after oral administration on-demand. The in...
Eligibility Criteria
Inclusion
- Male patients aged with premature ejaculation for more than 6 months.
- PEDT score ≥ 11
Exclusion
- IIEF-EF domain ≤ 21
- Serum Creatinine ≥ 2.5 mg/dl
- AST, ALT \> 3\*Upper limit of normal
- Subjects with hypotension(SBP/DBP\<90/50mmHg) or uncontrolled hypertension(SBP/DBP\>180/100mmHg)
- Subjects with chronic depression, psychiatric or schizophrenia,
- Subjects with alcohol, drug or substance abuse
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01798667
Start Date
January 1 2013
End Date
September 1 2013
Last Update
August 15 2013
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea