Phase 3 Trial of PED-1 in Male Patients With Premature Ejaculatio
Not Applicable
Recruiting
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0000199
- Lead Sponsor
- Symyoo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 180
Inclusion Criteria
1.Informed consent for subjects and partners
2.Men 20-65 ages
3.Stable monogamous relation at least for 6 mo
4.Premature Ejaculation Diagnosis Tool (PEDT) more than 9
5.At least 6 mo of premature ejaculation Hx
6.IELT of =< 2 min in >= 75% of evaluable events during 4 week screening period
Exclusion Criteria
1History of medical or psychiatric illness
2.Erectile dysfunction (<21 International Index of Erectile Function-3.Erectile Function (IIEF-EF) domain score) or other forms of sexual dysfunction
4.Partner sexual dysfunction
5.Known hypersensitivity to clomipramine and contraindications for clomipramine
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intravaginal ejaculation latency time (IELT)(seconds)
- Secondary Outcome Measures
Name Time Method Drug coitus interval time (hours)