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

NCT ID: NCT01203202

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

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-01-31

Brief Summary

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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

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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.

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 0

placebo

Group Type PLACEBO_COMPARATOR

Clomipramine

Intervention Type DRUG

15mg and 30mg on demand

PED 1

PED-1 (clomipramine 15mg)

Group Type EXPERIMENTAL

Clomipramine

Intervention Type DRUG

15mg and 30mg on demand

PED-2

PED-2 (Clomipramine 30mg)

Group Type EXPERIMENTAL

Clomipramine

Intervention Type DRUG

15mg and 30mg on demand

Interventions

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Clomipramine

15mg and 30mg on demand

Intervention Type DRUG

Other Intervention Names

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PED-1 PED-2

Eligibility Criteria

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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
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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Seoul St. Marry's Hospital

Principal Investigators

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Whan-Seok Choi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Marry's Hospital

Locations

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Ewha University Mok-dong 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 02

Identifier Type: -

Identifier Source: org_study_id