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Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation

Primary Purpose

Premature Ejaculation

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Clomipramine
Sponsored by
Symyoo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ejaculation focused on measuring PE, IELT, DCIT

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ewha University Mok-dong Hospital
  • Seoul St. Marry's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

PED 0

PED 1

PED-2

Arm Description

placebo

PED-1 (clomipramine 15mg)

PED-2 (Clomipramine 30mg)

Outcomes

Primary Outcome Measures

Fold cahnges of Intraviginal ejaculation latency time (IELT)

Secondary Outcome Measures

Drug coitus interval time

Full Information

First Posted
September 14, 2010
Last Updated
October 1, 2012
Sponsor
Symyoo
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1. Study Identification

Unique Protocol Identification Number
NCT01203202
Brief Title
Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation
Official Title
A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped Clinical Study to Evaluate the Tolerability and to Determine the Adequate Dosage of PED-1 and PED-2 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 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

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 (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.

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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PED 0
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
PED 1
Arm Type
Experimental
Arm Description
PED-1 (clomipramine 15mg)
Arm Title
PED-2
Arm Type
Experimental
Arm Description
PED-2 (Clomipramine 30mg)
Intervention Type
Drug
Intervention Name(s)
Clomipramine
Other Intervention Name(s)
PED-1, PED-2
Intervention Description
15mg and 30mg on demand
Primary Outcome Measure Information:
Title
Fold cahnges of Intraviginal ejaculation latency time (IELT)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Drug coitus interval time
Time Frame
4 week

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 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
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
Ewha University Mok-dong 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

Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation

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