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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01203202

Enrollment

104

Registered

2010-09-16

Start date

2010-09-30

Completion date

2011-01-31

Last updated

2012-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ejaculation

Keywords

PE, IELT, DCIT

Brief 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.

Detailed 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.

Interventions

DRUGClomipramine

15mg and 30mg on demand

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Fold cahnges of Intraviginal ejaculation latency time (IELT)	4 weeks

Secondary

Measure	Time frame
Drug coitus interval time	4 week

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026