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

NCT01798667 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2013-08-15

No results posted yet for this study

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

Interventions

DRUG

DA-8031

DRUG

Placebo

Placebo of DA-8031, undistinguishable

Sponsors & Collaborators

  • Dong-A Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Sae Woong Kim · Seoul St. Mary's Hospital

  • Du Geon Moon · Korea University Guro Hospital

  • Nam-Cheol Park · Pusan National University Hospital

  • Jae-Seung Paick · Seoul National University Hospital

  • Tai-Young Ahn · Asan Medical Center

  • Sung Won Lee · Samsung Medical Center

  • Ki Hak Moon · Yeongnam University Hospital

  • Kwangsung Park · Chonnam National University Hospital

  • Jong Kwan Park · Chonbuk National University Hospital

  • Dae Yul Yang · Kangdong Sacred Heart Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-04-30
Completion
2013-09-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01798667 on ClinicalTrials.gov