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Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 in Male Patients With Premature Ejaculation

Primary Purpose

Premature Ejaculation

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-8031
Placebo
Sponsored by
Dong-A Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ejaculation

Eligibility Criteria

20 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male patients aged with premature ejaculation for more than 6 months.
  • PEDT score ≥ 11

Exclusion Criteria:

  • IIEF-EF domain ≤ 21
  • Serum Creatinine ≥ 2.5 mg/dl
  • AST, ALT > 3*Upper limit of normal
  • Subjects with hypotension(SBP/DBP<90/50mmHg) or uncontrolled hypertension(SBP/DBP>180/100mmHg)
  • Subjects with chronic depression, psychiatric or schizophrenia,
  • Subjects with alcohol, drug or substance abuse

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

DA-8031 dose 1

DA-8031 dose 2

DA-8031 dose 3

Arm Description

PO administration

PO administration

PO administration

PO administration

Outcomes

Primary Outcome Measures

average IELT change

Secondary Outcome Measures

PEP, PGI
PEP(Primary ejaculation profile), PGI(Patient-reported global impression)

Full Information

First Posted
January 27, 2013
Last Updated
August 14, 2013
Sponsor
Dong-A Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01798667
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 in Male Patients With Premature Ejaculation
Official Title
A Randomized, Double-blind, Double-dummy, Placebo-controlled, Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 After Oral Administration in Male Patients With Premature Ejaculation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
This study is designed to evaluate the efficacy and safety of DA-8031 and to decide the optimal dose of DA-8031 in male patients with premature ejaculation after oral administration on-demand. The investigators hypothesized that newly-developed DA-8031 would effect in delaying ejaculation in patients with premature ejaculation (PE). Design: Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
PO administration
Arm Title
DA-8031 dose 1
Arm Type
Experimental
Arm Description
PO administration
Arm Title
DA-8031 dose 2
Arm Type
Experimental
Arm Description
PO administration
Arm Title
DA-8031 dose 3
Arm Type
Experimental
Arm Description
PO administration
Intervention Type
Drug
Intervention Name(s)
DA-8031
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo of DA-8031, undistinguishable
Primary Outcome Measure Information:
Title
average IELT change
Time Frame
From 0 week(baseline) to 8 week(end of treatment)
Secondary Outcome Measure Information:
Title
PEP, PGI
Description
PEP(Primary ejaculation profile), PGI(Patient-reported global impression)
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male patients aged with premature ejaculation for more than 6 months. PEDT score ≥ 11 Exclusion Criteria: IIEF-EF domain ≤ 21 Serum Creatinine ≥ 2.5 mg/dl AST, ALT > 3*Upper limit of normal Subjects with hypotension(SBP/DBP<90/50mmHg) or uncontrolled hypertension(SBP/DBP>180/100mmHg) Subjects with chronic depression, psychiatric or schizophrenia, Subjects with alcohol, drug or substance abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung Won Lee
Email
drswlee@skku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sae Woong Kim
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Du Geon Moon
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nam-Cheol Park
Organizational Affiliation
Pusan National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae-Seung Paick
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tai-Young Ahn
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sung Won Lee
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ki Hak Moon
Organizational Affiliation
Yeongnam University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kwangsung Park
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jong Kwan Park
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dae Yul Yang
Organizational Affiliation
Kangdong Sacred Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Won Lee

12. IPD Sharing Statement

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Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 in Male Patients With Premature Ejaculation

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