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

August 14, 2013 updated by: Dong-A Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Sung Won Lee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
PO administration
Drug: Placebo
Placebo of DA-8031, undistinguishable
Experimental: DA-8031 dose 1
PO administration
Drug: DA-8031
Experimental: DA-8031 dose 2
PO administration
Drug: DA-8031
Experimental: DA-8031 dose 3
PO administration
Drug: DA-8031

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
average IELT change
Time Frame: From 0 week(baseline) to 8 week(end of treatment)
From 0 week(baseline) to 8 week(end of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PEP, PGI
Time Frame: 8 weeks
PEP(Primary ejaculation profile), PGI(Patient-reported global impression)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Sae Woong Kim, Seoul St. Mary's Hospital
  • Principal Investigator: Du Geon Moon, Korea University Guro Hospital
  • Principal Investigator: Nam-Cheol Park, Pusan National University Hospital
  • Principal Investigator: Jae-Seung Paick, Seoul National University Hospital
  • Principal Investigator: Tai-Young Ahn, Asan Medical Center
  • Principal Investigator: Sung Won Lee, Samsung Medical Center
  • Principal Investigator: Ki Hak Moon, Yeongnam University Hospital
  • Principal Investigator: Kwangsung Park, Chonnam National University Hospital
  • Principal Investigator: Jong Kwan Park, Chonbuk National University Hospital
  • Principal Investigator: Dae Yul Yang, Kangdong Sacred Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

January 27, 2013

First Submitted That Met QC Criteria

February 22, 2013

First Posted (Estimate)

February 26, 2013

Study Record Updates

Last Update Posted (Estimate)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 14, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA8031_PE_II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Premature Ejaculation

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe