Trial of PED-1 in Male Patients With Premature Ejaculation

A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped, Multi-center Clinical Study to Evaluate the Safety and Efficacy of PED-1 in Male Patients With Premature Ejaculation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01439984

Enrollment

159

Registered

2011-09-23

Start date

2011-09-30

Completion date

2012-06-30

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 is more effective than Placebo in the treatment of premature ejaculation.

Detailed 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.

Interventions

DRUGClomipramine

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

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 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

Design outcomes

Primary

Measure	Time frame
Intravaginal ejaculation latency time (IELT)(seconds)	12 weeks

Secondary

Measure	Time frame
Drug coitus interval time (hours)	12 weeks

Countries

South Korea

Outcome results

None listed

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