Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation
- Registration Number
- NCT01203202
- Lead Sponsor
- Symyoo
- Brief Summary
The purpose of this study is to evaluate whether PED-1 (15mg) and PED-2 (30mg) are tolerable and effective in the treatment of premature ejaculation.
- Detailed Description
This study is to evaluate whether PED-1 and PED2 are tolerable and effective in the treatment of premature ejaculation. The patients will be randomized and allocated to three treatment groups into placebo, PED-1, and PED-2. The creteria for IELT for enrollment will be \> or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT will be used. The patients ungone drug free baseline line period will take test drugs for 4 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 104
Inclusion Criteria
- Informed consent for subjects and partdners
- Men 20-65
- stable monogamous relation at least for 6 mn
- PEDT more than 9
- at least 6 Mn of premature ejaculation Hx
- IELT of =< 2 min in >= 75% of evaluable events during 4 week secreening period
Exclusion Criteria
- Hx of medical or psychiartric illness
- erectile dysfunction (<21 IIEF EF domain score) or other forms of sexual dysfunction
- Partner sexual dysfunction
- known hypersensitivity to clomipramine and contraindications for clomipramine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PED 0 Clomipramine placebo PED 1 Clomipramine PED-1 (clomipramine 15mg) PED-2 Clomipramine PED-2 (Clomipramine 30mg)
- Primary Outcome Measures
Name Time Method Fold cahnges of Intraviginal ejaculation latency time (IELT) 4 weeks
- Secondary Outcome Measures
Name Time Method Drug coitus interval time 4 week
Trial Locations
- Locations (2)
Ewha University Mok-dong Hospital
🇰🇷Seoul, Korea, Republic of
Seoul St. Marry's Hospital
🇰🇷Seoul, Korea, Republic of