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Trial of PED-1 in Male Patients With Premature Ejaculation

NCT ID: NCT01439984

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Premature Ejaculation

Keywords

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PE IELT DCIT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PED-1

PED-1 (Clomipramine 15 mg)

Group Type EXPERIMENTAL

Clomipramine

Intervention Type DRUG

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

placebo

Group Type PLACEBO_COMPARATOR

Clomipramine

Intervention Type DRUG

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

Interventions

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Clomipramine

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

Intervention Type DRUG

Other Intervention Names

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PED-1

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Symyoo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Whan-Seok Choi, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Marry's Hospital

Locations

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Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, South Korea

Site Status

National Health Insurance Corporation Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Site Status

Uijeongbu St.Marry's Hospital

Uijeongbu-si, Gyeonggi-do, South Korea

Site Status

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status

Seoul St.Marry's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CTC-PE-01

Identifier Type: -

Identifier Source: org_study_id