Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044
Lead Sponsor:
Yuhan Corporation
Conditions:
Premature Ejaculation
Eligibility:
MALE
20-60 years
Phase:
PHASE1
PHASE2
Brief Summary
safety and tolerability, pharmacokinetics/efficacy of an escalating, repeat doses of YHD1044 in premature ejaculation
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01419470
Start Date
February 1 2011
End Date
May 1 2012
Last Update
August 1 2012
Active Locations (1)
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1
Samsung medical center
Seoul, Seoul, South Korea