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

This study is currently recruiting participants.
Verified August 2013 by Dong-A Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01798667
First received: January 27, 2013
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Premature Ejaculation
Drug: DA-8031
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Dong-A Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • average IELT change [ Time Frame: From 0 week(baseline) to 8 week(end of treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PEP, PGI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    PEP(Primary ejaculation profile), PGI(Patient-reported global impression)


Estimated Enrollment: 220
Study Start Date: January 2013
Estimated Study Completion Date: September 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01798667

Contacts
Contact: Sung Won Lee drswlee@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Sung Won Lee         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01798667     History of Changes
Other Study ID Numbers: DA8031_PE_II
Study First Received: January 27, 2013
Last Updated: August 14, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014