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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01798667

Enrollment

220

Registered

2013-02-26

Start date

2013-01-31

Completion date

2013-09-30

Last updated

2013-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ejaculation

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

Interventions

DRUGDA-8031

DRUGPlacebo

Placebo of DA-8031, undistinguishable

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
average IELT change	From 0 week(baseline) to 8 week(end of treatment)

Secondary

Measure	Time frame	Description
PEP, PGI	8 weeks	PEP(Primary ejaculation profile), PGI(Patient-reported global impression)

Countries

South Korea

Contacts

Primary ContactSung Won Lee

drswlee@skku.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026