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

Premature Ejaculation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01798667
• Other study ID #: DA8031_PE_II
• Status: Recruiting
• Phase: Phase 2
• First received: January 27, 2013
• Last updated: August 14, 2013
• Start date: January 2013
• Est. completion date: September 2013

Study information

• Verified date: August 2013
• Source: Dong-A ST Co., Ltd.
• Contact: Sung Won Lee
• Email: drswlee[@]skku.edu
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: September 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

Drug:
• DA-8031

• Placebo
Placebo of DA-8031, undistinguishable

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average IELT change		From 0 week(baseline) to 8 week(end of treatment)	No
Secondary	PEP, PGI	PEP(Primary ejaculation profile), PGI(Patient-reported global impression)	8 weeks	No