Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044

Phase 1

Completed

• Conditions: Premature Ejaculation
• Interventions: Drug: dapoxetine

• Registration Number: NCT01419470
• Lead Sponsor: Yuhan Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-08-17
• Study First Posted: 2011-08-18
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-31
• Last Update Posted: 2012-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YHD1044 V	dapoxetine	-
YHD1044 I	dapoxetine	-
YHD1044 III	dapoxetine	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	throughout the study up to day 28	through physical examination, laboratory result, vital sign,ECG etc.

Secondary Outcome Measures

Name	Time	Method
Efficacy(IELT)	13days, 28days	change from baseline in IELT at the Day 13, 28
Cmax(Cmax,ss), Cmin,ss, AUCinf, AUCt, Tmax, CL/F	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)

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of