Premature EjaculationPhase 1/2NCT01419470
Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044
A Phase 1/2 study testing dapoxetine in people with Premature Ejaculation, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
safety and tolerability, pharmacokinetics/efficacy of an escalating, repeat doses of YHD1044 in premature ejaculation Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- dapoxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2011to May 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ⅰ/Ⅱ Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044 After Oral Administration in Premature Ejaculation Patients
safety and tolerability, pharmacokinetics/efficacy of an escalating, repeat doses of YHD1044 in premature ejaculation
- Conditions
- Premature Ejaculation
- Being tested
- dapoxetine
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dapoxetineDrug
Also called Priligy
- multiple dosing
- 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine
| Study group | Role | What they receive |
|---|---|---|
| YHD1044 I | Experimental | Not described Receives: Drug: dapoxetine |
| YHD1044 III | Experimental | Not described Receives: Drug: dapoxetine |
| YHD1044 V | Experimental | Not described Receives: Drug: dapoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
through physical examination, laboratory result, vital sign,ECG etc.
Measured: throughout the study up to day 28
Secondary outcomes (2)
Efficacy(IELT)
change from baseline in IELT at the Day 13, 28
Measured: 13days, 28days
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)
Measured: specified timepoints in the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419470
- Sponsor's protocol ID
- YCD173
- Status last verified
- Jul 2012
- First submitted
- 9 Jun 2011
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅰ/Ⅱ Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044 After Oral Administration in Premature Ejaculation Patients
- ClinicalTrials.gov ID
- NCT01419470
- Acronym / sponsor ID
- YCD173
- Conditions
- Premature Ejaculation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
safety and tolerability, pharmacokinetics/efficacy of an escalating, repeat doses of YHD1044 in premature ejaculation
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YHD1044 I | Experimental | Drug: dapoxetine |
| YHD1044 III | Experimental | Drug: dapoxetine |
| YHD1044 V | Experimental | Drug: dapoxetine |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dapoxetineAlso: Priligy1. multiple dosing 2. 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine | Drug | YHD1044 I, YHD1044 III, YHD1044 V |
Primary outcome
Safety and tolerability
Time frame: throughout the study up to day 28
through physical examination, laboratory result, vital sign,ECG etc.
2 secondary outcomes
Efficacy(IELT)
Time frame: 13days, 28days
Cmax(Cmax,ss), Cmin,ss, AUCinf, AUCt, Tmax, CL/F
Time frame: specified timepoints in the protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing dapoxetine in people with Premature Ejaculation, run by Yuhan Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: throughout the study up to day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2012.