Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044
Phase Ⅰ/Ⅱ Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044 After Oral Administration in Premature Ejaculation Patients
1 other identifier
interventional
24
1 country
1
Brief Summary
safety and tolerability, pharmacokinetics/efficacy of an escalating, repeat doses of YHD1044 in premature ejaculation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 9, 2011
CompletedFirst Posted
Study publicly available on registry
August 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedAugust 1, 2012
July 1, 2012
1.2 years
June 9, 2011
July 31, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability
through physical examination, laboratory result, vital sign,ECG etc.
throughout the study up to day 28
Secondary Outcomes (2)
Efficacy(IELT)
13days, 28days
Cmax(Cmax,ss), Cmin,ss, AUCinf, AUCt, Tmax, CL/F
specified timepoints in the protocol
Study Arms (3)
YHD1044 I
EXPERIMENTALYHD1044 III
EXPERIMENTALYHD1044 V
EXPERIMENTALInterventions
1. multiple dosing 2. 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung medical center
Seoul, Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2011
First Posted
August 18, 2011
Study Start
February 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
August 1, 2012
Record last verified: 2012-07