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Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044

Primary Purpose

Premature Ejaculation

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dapoxetine
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Premature Ejaculation

Eligibility Criteria

20 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung medical center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

YHD1044 I

YHD1044 III

YHD1044 V

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability
through physical examination, laboratory result, vital sign,ECG etc.

Secondary Outcome Measures

Efficacy(IELT)
change from baseline in IELT at the Day 13, 28
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)

Full Information

First Posted
June 9, 2011
Last Updated
July 31, 2012
Sponsor
Yuhan Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01419470
Brief Title
Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044
Official Title
Phase Ⅰ/Ⅱ Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044 After Oral Administration in Premature Ejaculation Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YHD1044 I
Arm Type
Experimental
Arm Title
YHD1044 III
Arm Type
Experimental
Arm Title
YHD1044 V
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
dapoxetine
Other Intervention Name(s)
Priligy
Intervention Description
multiple dosing 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
through physical examination, laboratory result, vital sign,ECG etc.
Time Frame
throughout the study up to day 28
Secondary Outcome Measure Information:
Title
Efficacy(IELT)
Description
change from baseline in IELT at the Day 13, 28
Time Frame
13days, 28days
Title
Cmax(Cmax,ss), Cmin,ss, AUCinf, AUCt, Tmax, CL/F
Description
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)
Time Frame
specified timepoints in the protocol

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Samsung medical center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044

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