Status:
COMPLETED
Trial of PED-1 in Male Patients With Premature Ejaculation
Lead Sponsor:
Symyoo
Conditions:
Premature Ejaculation
Eligibility:
MALE
20-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the treatment of premature ejaculation.
Detailed Description
This study is to evaluate whether PED-1 is effective than Placebo in the treatment of premature ejaculation. The patients will be randomized and allocated to two treatment groups into placebo, PED-1. ...
Eligibility Criteria
Inclusion
- Informed consent for subjects and partners
- Men 20-65 ages
- Stable monogamous relation at least for 6 mo
- Premature Ejaculation Diagnosis Tool (PEDT) more than 9
- At least 6 mo of premature ejaculation Hx
- IELT of =\< 2 min in \>= 75% of evaluable events during 4 week screening period
Exclusion
- History of medical or psychiatric illness
- Erectile dysfunction (\<21 International Index of Erectile Function-Erectile Function (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 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT01439984
Start Date
September 1 2011
End Date
June 1 2012
Last Update
October 3 2012
Active Locations (5)
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1
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea
2
National Health Insurance Corporation Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
3
Uijeongbu St.Marry's Hospital
Uijeongbu-si, Gyeonggi-do, South Korea
4
Ewha Womans University Mokdong Hospital
Seoul, South Korea