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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


Clinical Trial Description

n/a


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


NCT number NCT01798667
Study type Interventional
Source Dong-A ST Co., Ltd.
Contact Sung Won Lee
Email drswlee@skku.edu
Status Recruiting
Phase Phase 2
Start date January 2013
Completion date September 2013

See also
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Completed NCT01184105 - A Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment of Premature Ejaculation Phase 1
Completed NCT01203202 - Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation Phase 2
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Completed NCT00556478 - Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation Phase 2/Phase 3
Not yet recruiting NCT05556083 - Sildenafil Added Effect in Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE) Phase 2
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Recruiting NCT02571101 - A Phase 2 Study of On-demand Therapy With Clomipramine and Sildenafil Combination in Premature Ejaculation Phase 2
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Completed NCT02794454 - A Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health N/A
Completed NCT02297152 - A New Treatment for Premature Ejaculation? N/A