Skip to main content
OpenTrials
Completed

NCT Number: NCT01419470

Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Premature Ejaculation Ejaculatory Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

20 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Samsung medical center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapoxetine

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

Other names: Priligy

Primary outcomes

  1. Safety and tolerability

    Time frame: throughout the study up to day 28

    through physical examination, laboratory result, vital sign,ECG etc.

Secondary outcomes

  1. Efficacy(IELT)

    Time frame: 13days, 28days

    change from baseline in IELT at the Day 13, 28

  2. Cmax(Cmax,ss), Cmin,ss, AUCinf, AUCt, Tmax, CL/F

    Time frame: specified timepoints in the protocol

    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)

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

Phase Ⅰ/Ⅱ Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044 After Oral Administration in Premature Ejaculation Patients

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 18, 2011
Registry last updated
Aug 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.