Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 in Male Patients With Premature Ejaculation
- Registration Number
- NCT01798667
- Lead Sponsor
- Dong-A Pharmaceutical Co., Ltd.
- 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 investigators hypothesized that newly-developed DA-8031 would effect in delaying ejaculation in patients with premature ejaculation (PE).
Design:
Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 220
Inclusion Criteria
- Male patients aged with premature ejaculation for more than 6 months.
- PEDT score ≥ 11
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DA-8031 dose 1 DA-8031 PO administration DA-8031 dose 2 DA-8031 PO administration Placebo Placebo PO administration DA-8031 dose 3 DA-8031 PO administration
- Primary Outcome Measures
Name Time Method average IELT change From 0 week(baseline) to 8 week(end of treatment)
- Secondary Outcome Measures
Name Time Method PEP, PGI 8 weeks PEP(Primary ejaculation profile), PGI(Patient-reported global impression)
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of