Safety, Tolerability, Pharmacokinetics and Efficacy of YH... | NCT01419470

Studies
Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044

NCT01419470

Sponsor

Yuhan Corporation

Status

Completed

Last Update Posted

Aug 1, 2012Estimated

Enrollment

24Actual

Phase

Phase 1Phase 2

Conditions

Premature Ejaculation

Interventions

dapoxetine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Jun 9, 2011

First Submission Date that Met QC Criteria

Aug 17, 2011

First Posted Date

Aug 18, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2012

Last Update Posted Date

Aug 1, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
YHD1044 I	Experimental	Drug: dapoxetine
YHD1044 III	Experimental	Drug: dapoxetine
YHD1044 V	Experimental	Drug: dapoxetine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dapoxetine	Drug	multiple dosing 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine	YHD1044 I YHD1044 III

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability	through physical examination, laboratory result, vital sign,ECG etc.	throughout the study up to day 28

Secondary Outcomes

Measure	Description	Time Frame
Efficacy(IELT)	change from baseline in IELT at the Day 13, 28	13days, 28days
Cmax(Cmax,ss), Cmin,ss, AUCinf, AUCt, Tmax, CL/F	Cmax(Cmax,ss), Cmin,ss, AUCinf, AUCt will be assessed. Samping time point: intensive sampling(Day1~2, Day14~15)& intermittent sampling(Day3~Day 28 except intensive sampling period)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000097910	Ejaculatory Dysfunction
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases