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

Dong-A Pharmaceutical Co., Ltd.220 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

220

Conditions

Premature Ejaculation

Interventions

DA-8031DRUG

PlaceboDRUG

Placebo of DA-8031, undistinguishable

Eligibility

Sex: MALEMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

average IELT change

Time frame: From 0 week(baseline) to 8 week(end of treatment)

Secondary Outcomes

PEP, PGI

PEP(Primary ejaculation profile), PGI(Patient-reported global impression)

Time frame: 8 weeks

Central Contacts

Sung Won Lee

CONTACT

drswlee@skku.edu

Data from ClinicalTrials.gov

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