Trial of PED-1 in Male Patients With Premature Ejaculation

Symyoo

Status and phase

Completed

Phase 3

Conditions

Premature Ejaculation

Treatments

Drug: Clomipramine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01439984

CTC-PE-01

Details and patient eligibility

About

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

Full 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.

Enrollment

159 patients

Sex

Male

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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