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Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044

NCT ID: NCT01419470

Last Updated: 2012-08-01

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

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-05-31

Brief Summary

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safety and tolerability, pharmacokinetics/efficacy of an escalating, repeat doses of YHD1044 in premature ejaculation

Detailed Description

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Conditions

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Premature Ejaculation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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YHD1044 I

Group Type EXPERIMENTAL

dapoxetine

Intervention Type DRUG

1. multiple dosing
2. 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine

YHD1044 III

Group Type EXPERIMENTAL

dapoxetine

Intervention Type DRUG

1. multiple dosing
2. 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine

YHD1044 V

Group Type EXPERIMENTAL

dapoxetine

Intervention Type DRUG

1. multiple dosing
2. 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine

Interventions

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dapoxetine

1. multiple dosing
2. 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine

Intervention Type DRUG

Other Intervention Names

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Priligy

Eligibility Criteria

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Inclusion Criteria

* Patient is in a stable, monogamous sexual relationship with the same woman for at least 6 months and plans to maintain this relationship for the duration of the study
* History of premature ejaculation in the 6 months before study initiation
* History of intravaginal ejaculatory latency time (IELT) of \< = 2 minutes in at least half of events
* Premature Ejaculation Diagnostic Tool (PEDT) \> =11
* 6 domains of International Index of Erectile Function(IIEF) \>= 21
* Patient and partner must agree to attempt sexual intercourse at minimum intervals specified in the protocol
* Patient's partner must have a negative urine pregnancy test at time of screening

Exclusion Criteria

* Medical history which affects ADME in the past 3 years
* Clinically significant and active disorder in ophthalmic system, gastro-intestine, cardiovascular, respiratory system, endocrine system, autoimmune system or malignant tumor,
* Subjects with clinically significant observations considered as unsuitable based on medical judgment in the physical examination and clinical laboratory tests or a medical history
* History of psychological disease
* Clinically significant allergic disease
* Hypersensitivity to TCA, SSRIs(Clomipramine, sertraline, fluoxetine, dapoxetine)
* Taken dapoxetine within 3 months
* Using other forms of therapy for treatment of PE (behavioral therapy or medications applied to the skin)
* Taken another investigational drug within 1 month
* History of drug abuse
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samsung medical center

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YCD173

Identifier Type: -

Identifier Source: org_study_id