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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798667
Recruitment Status : Unknown
Verified August 2013 by Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. ).
Recruitment status was:  Recruiting
First Posted : February 26, 2013
Last Update Posted : August 15, 2013
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. )

Study Description
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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


Condition or disease Intervention/treatment Phase
Premature Ejaculation Drug: DA-8031 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2013
Actual Primary Completion Date : April 2013
Estimated Study Completion Date : September 2013
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. average IELT change [ Time Frame: From 0 week(baseline) to 8 week(end of treatment) ]

Secondary Outcome Measures :
  1. PEP, PGI [ Time Frame: 8 weeks ]
    PEP(Primary ejaculation profile), PGI(Patient-reported global impression)


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798667


Contacts
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Contact: Sung Won Lee drswlee@skku.edu

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Sung Won Lee         
Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
Investigators
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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
More Information
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Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01798667    
Other Study ID Numbers: DA8031_PE_II
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: August 15, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
 Pregnancy Complications
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders