Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044

Premature Ejaculation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419470
• Other study ID #: YCD173
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 9, 2011
• Last updated: July 31, 2012
• Start date: February 2011
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	through physical examination, laboratory result, vital sign,ECG etc.	throughout the study up to day 28	Yes
Secondary	Efficacy(IELT)	change from baseline in IELT at the Day 13, 28	13days, 28days	Yes
Secondary	Cmax(Cmax,ss), Cmin,ss, AUCinf, AUCt, Tmax, CL/F	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)	specified timepoints in the protocol	Yes