Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation

Premature Ejaculation Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped Clinical Study to Evaluate the Tolerability and to Determine the Adequate Dosage of PED-1 and PED-2 in Male Patients With Premature Ejaculation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203202
• Other study ID #: CTC PE 02
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2010
• Last updated: October 1, 2012
• Start date: September 2010
• Est. completion date: January 2011

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 (15mg) and PED-2 (30mg) are tolerable and effective in the treatment of premature ejaculation.

Description:

This study is to evaluate whether PED-1 and PED2 are tolerable and effective in the treatment of premature ejaculation. The patients will be randomized and allocated to three treatment groups into placebo, PED-1, and PED-2. The creteria for IELT for enrollment will be > or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT will be used. The patients ungone drug free baseline line period will take test drugs for 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Informed consent for subjects and partdners

• Men 20-65

• stable monogamous relation at least for 6 mn

• PEDT more than 9

• at least 6 Mn of premature ejaculation Hx

• IELT of =< 2 min in >= 75% of evaluable events during 4 week secreening period

Exclusion Criteria:

• Hx of medical or psychiartric illness

• erectile dysfunction (<21 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
15mg and 30mg on demand

Locations

Country	Name	City	State
Korea, Republic of	Ewha University Mok-dong Hospital	Seoul
Korea, Republic of	Seoul St. Marry's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Symyoo

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fold cahnges of Intraviginal ejaculation latency time (IELT)		4 weeks	No
Secondary	Drug coitus interval time		4 week	No