Back to resultsTrial of PED-1 in Male Patients With Premature Ejaculation
Primary Purpose
Premature Ejaculation
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Clomipramine
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ejaculation focused on measuring PE, IELT, DCIT
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Inje University Ilsan Paik Hospital
- National Health Insurance Corporation Ilsan Hospital
- Uijeongbu St.Marry's Hospital
- Ewha Womans University Mokdong Hospital
- Seoul St.Marry's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PED-1
placebo
Arm Description
PED-1 (Clomipramine 15 mg)
Outcomes
Primary Outcome Measures
Intravaginal ejaculation latency time (IELT)(seconds)
Secondary Outcome Measures
Drug coitus interval time (hours)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01439984
Brief Title
Trial of PED-1 in Male Patients With Premature Ejaculation
Official Title
A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped, Multi-center Clinical Study to Evaluate the Safety and Efficacy of PED-1 in Male Patients With Premature Ejaculation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Symyoo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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. The criteria for Intravaginal Ejaculation Latency Time(IELT) for enrollment will be > or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT(Premature Ejaculation Diagnosis Tool) will be used. The patients undergone drug free baseline period will take test drugs for 12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation
Keywords
PE, IELT, DCIT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PED-1
Arm Type
Experimental
Arm Description
PED-1 (Clomipramine 15 mg)
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Clomipramine
Other Intervention Name(s)
PED-1
Intervention Description
Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks
Primary Outcome Measure Information:
Title
Intravaginal ejaculation latency time (IELT)(seconds)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Drug coitus interval time (hours)
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Whan-Seok Choi, MD,PhD
Organizational Affiliation
Seoul St. Marry's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Ilsan Paik Hospital
City
Goyang-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
National Health Insurance Corporation Ilsan Hospital
City
Goyang-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Uijeongbu St.Marry's Hospital
City
Uijeongbu-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul St.Marry's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Trial of PED-1 in Male Patients With Premature Ejaculation
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