Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation

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