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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

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

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


Detailed Summary:
Sponsor: Dong-A Pharmaceutical Co., Ltd.

Current Primary Outcome: average IELT change [ Time Frame: From 0 week(baseline) to 8 week(end of treatment) ]

Original Primary Outcome: Same as current

Current Secondary Outcome: PEP, PGI [ Time Frame: 8 weeks ]

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


Original Secondary Outcome: Same as current

Information By: Dong-A ST Co., Ltd.

Dates:
Date Received: January 27, 2013
Date Started: January 2013
Date Completion: September 2013
Last Updated: August 14, 2013
Last Verified: August 2013