Trial of PED-1 in Male Patients With Premature Ejaculation

Phase 3

Completed

• Conditions: Premature Ejaculation
• Interventions: Drug: Clomipramine

• Registration Number: NCT01439984
• Lead Sponsor: Symyoo

Brief Summary

The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the treatment of premature ejaculation.

Detailed Description

This study is to evaluate whether PED-1 is effective than Placebo in the treatment of premature ejaculation. The patients will be randomized and allocated to two treatment groups into placebo, PED-1. The criteria for Intravaginal Ejaculation Latency Time(IELT) for enrollment will be \> or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT(Premature Ejaculation Diagnosis Tool) will be used. The patients undergone drug free baseline period will take test drugs for 12 weeks.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-18
• Study First Submitted QC: 2011-09-22
• Study First Posted: 2011-09-23
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-01
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 159

Inclusion Criteria

• Informed consent for subjects and partners
• Men 20-65 ages
• Stable monogamous relation at least for 6 mo
• Premature Ejaculation Diagnosis Tool (PEDT) more than 9
• At least 6 mo of premature ejaculation Hx
• IELT of =< 2 min in >= 75% of evaluable events during 4 week screening period

Exclusion Criteria

• History of medical or psychiatric illness
• Erectile dysfunction (<21 International Index of Erectile Function-Erectile Function (IIEF-EF) domain score) or other forms of sexual dysfunction
• Partner sexual dysfunction
• Known hypersensitivity to clomipramine and contraindications for clomipramine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Clomipramine	-
PED-1	Clomipramine	PED-1 (Clomipramine 15 mg)

Primary Outcome Measures

Name	Time	Method
Intravaginal ejaculation latency time (IELT)(seconds)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Drug coitus interval time (hours)	12 weeks

Trial Locations

Locations (5)

Inje University Ilsan Paik Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

National Health Insurance Corporation Ilsan Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

Uijeongbu St.Marry's Hospital; 🇰🇷 Uijeongbu-si, Gyeonggi-do, Korea, Republic of

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul St.Marry's Hospital; 🇰🇷 Seoul, Korea, Republic of