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Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01419470
First received: June 9, 2011
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Premature Ejaculation
 Drug: dapoxetine
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Phase Ⅰ/Ⅱ Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044 After Oral Administration in Premature Ejaculation Patients

Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: throughout the study up to day 28 ] [ Designated as safety issue: Yes ]
    through physical examination, laboratory result, vital sign,ECG etc.


Secondary Outcome Measures:
  • Efficacy(IELT) [ Time Frame: 13days, 28days ] [ Designated as safety issue: Yes ]
    change from baseline in IELT at the Day 13, 28

  • Cmax(Cmax,ss), Cmin,ss, AUCinf, AUCt, Tmax, CL/F [ Time Frame: specified timepoints in the protocol ] [ Designated as safety issue: Yes ]
    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)


Enrollment: 24
Study Start Date: February 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YHD1044 I Drug: dapoxetine
  1. multiple dosing
  2. 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine
Other Name: Priligy
Experimental: YHD1044 III Drug: dapoxetine
  1. multiple dosing
  2. 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine
Other Name: Priligy
Experimental: YHD1044 V Drug: dapoxetine
  1. multiple dosing
  2. 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine
Other Name: Priligy

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419470

Locations
Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
  More Information

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01419470     History of Changes
Other Study ID Numbers: YCD173
Study First Received: June 9, 2011
Last Updated: July 31, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013