Trial of PED-1 in Male Patients With Premature Ejaculation

Symyoo159 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

159

Conditions

Premature Ejaculation

Interventions

ClomipramineDRUG

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

Eligibility

Sex: MALEMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (5)

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, South Korea

National Health Insurance Corporation Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Uijeongbu St.Marry's Hospital

Uijeongbu-si, Gyeonggi-do, South Korea

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Intravaginal ejaculation latency time (IELT)(seconds)

Time frame: 12 weeks

Secondary Outcomes

Drug coitus interval time (hours)

Time frame: 12 weeks

Data from ClinicalTrials.gov

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