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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Dong-A ST Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST 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 ST 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 ST 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 ST 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:
Premature Ejaculation
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014