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

Phase 2CompletedNCT01203202

Symyoo104 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

104

Conditions

Premature Ejaculation

Interventions

ClomipramineDRUG

15mg and 30mg on demand

Eligibility

Sex: MALEMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Ewha University Mok-dong Hospital

Seoul, South Korea

Seoul St. Marry's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Fold cahnges of Intraviginal ejaculation latency time (IELT)

Time frame: 4 weeks

Secondary Outcomes

Drug coitus interval time

Time frame: 4 week

Data from ClinicalTrials.gov

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