Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044

Yuhan

Status and phase

Completed

Phase 2

Phase 1

Conditions

Premature Ejaculation

Treatments

Drug: dapoxetine

Study type

Interventional

Funder types

Industry

Identifiers

YCD173

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

Male

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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