Trial of PED-1 in Male Patients With Premature Ejaculation

Premature Ejaculation Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped, Multi-center Clinical Study to Evaluate the Safety and Efficacy of PED-1 in Male Patients With Premature Ejaculation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439984
• Other study ID #: CTC-PE-01
• Status: Completed
• Phase: Phase 3
• First received: September 18, 2011
• Last updated: October 1, 2012
• Start date: September 2011
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: Symyoo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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

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:
• Clomipramine
Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	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	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Seoul St.Marry's Hospital	Seoul
Korea, Republic of	Uijeongbu St.Marry's Hospital	Uijeongbu-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Symyoo

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intravaginal ejaculation latency time (IELT)(seconds)		12 weeks	No
Secondary	Drug coitus interval time (hours)		12 weeks	No