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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014