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

NCT01798667 | Unknown Phase 2

• 1 other identifier: DA8031_PE_II
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

Conditions

Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

• average IELT change

  From 0 week(baseline) to 8 week(end of treatment)

Secondary Outcomes (1)

• PEP, PGI

  8 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

PO administration

Drug: Placebo

DA-8031 dose 1

EXPERIMENTAL

PO administration

Drug: DA-8031

DA-8031 dose 2

EXPERIMENTAL

PO administration

Drug: DA-8031

DA-8031 dose 3

EXPERIMENTAL

PO administration

Drug: DA-8031

Interventions

DA-8031 DRUG

DA-8031 dose 1; DA-8031 dose 2; DA-8031 dose 3

Placebo DRUG

Placebo of DA-8031, undistinguishable

Placebo

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Premature Ejaculation

Interventions

DA 8031

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Won Lee

CONTACT

drswlee@skku.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2013
• First Posted: February 26, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 15, 2013

Record last verified: 2013-08

Locations

KR (1)