Status:
COMPLETED
Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation
Lead Sponsor:
Symyoo
Conditions:
Premature Ejaculation
Eligibility:
MALE
20-65 years
Phase:
PHASE2
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 pla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01203202
Start Date
September 1 2010
End Date
January 1 2011
Last Update
October 3 2012
Active Locations (2)
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1
Ewha University Mok-dong Hospital
Seoul, South Korea
2
Seoul St. Marry's Hospital
Seoul, South Korea