Premature EjaculationPhase 2NCT01798667
Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 in Male Patients With Premature Ejaculation
A Phase 2 study testing DA-8031 in people with Premature Ejaculation, run by Dong-A Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This study is designed to evaluate the efficacy and safety of DA-8031 and to decide the optimal dose of DA-8031 in male patients with premature ejaculation after oral administration on-demand. Read more about this study
- Who is it for?
- Ages 20 to 64 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- DA-8031
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Sep 2013
- Phase
- Phase 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 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients aged with premature ejaculation for more than 6 months.
- PEDT score ≥ 11
Who cannot join
- IIEF-EF domain ≤ 21
- Serum Creatinine ≥ 2.5 mg/dl
- AST, ALT > 3*Upper limit of normal
- Subjects with hypotension(SBP/DBP<90/50mmHg) or uncontrolled hypertension(SBP/DBP>180/100mmHg)
- Subjects with chronic depression, psychiatric or schizophrenia,
- Subjects with alcohol, drug or substance abuse
Trial locations and contacts
1 site in 1 country.
Sung Won Lee contact
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Sung Won Lee
About this study
Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 After Oral Administration in Male Patients With Premature Ejaculation
This study is designed to evaluate the efficacy and safety of DA-8031 and to decide the optimal dose of DA-8031 in male patients with premature ejaculation after oral administration on-demand.
The investigators hypothesized that newly-developed DA-8031 would effect in delaying ejaculation in patients with premature ejaculation (PE).
Design:
Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design
- Conditions
- Premature Ejaculation
- Being tested
- DA-8031, Placebo
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-8031Drug
PlaceboDrug
Placebo of DA-8031, undistinguishable
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | PO administration Receives: Drug: Placebo |
| DA-8031 dose 1 | Experimental | PO administration Receives: Drug: DA-8031 |
| DA-8031 dose 2 | Experimental | PO administration Receives: Drug: DA-8031 |
| DA-8031 dose 3 | Experimental | PO administration Receives: Drug: DA-8031 |
What is being measured
The primary outcome is the main question the study is designed to answer.
average IELT change
Measured: From 0 week(baseline) to 8 week(end of treatment)
Secondary outcomes (1)
PEP, PGI
PEP(Primary ejaculation profile), PGI(Patient-reported global impression)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2013
- Study completionSep 2013 (estimated)
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sae Woong Kim, Principal investigator, Seoul St. Mary's HospitalDu Geon Moon, Principal investigator, Korea University Guro HospitalNam-Cheol Park, Principal investigator, Pusan National University HospitalJae-Seung Paick, Principal investigator, Seoul National University HospitalTai-Young Ahn, Principal investigator, Asan Medical CenterSung Won Lee, Principal investigator, Samsung Medical CenterKi Hak Moon, Principal investigator, Yeongnam University HospitalKwangsung Park, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798667
- Sponsor's protocol ID
- DA8031_PE_II
- Status last verified
- Aug 2013
- First submitted
- 27 Jan 2013
- Last updated
- 15 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Placebo-controlled, Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 After Oral Administration in Male Patients With Premature Ejaculation
- ClinicalTrials.gov ID
- NCT01798667
- Acronym / sponsor ID
- DA8031_PE_II
- Conditions
- Premature Ejaculation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2013 (estimated)
- First posted
- 26 Feb 2013 (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.
This study is designed to evaluate the efficacy and safety of DA-8031 and to decide the optimal dose of DA-8031 in male patients with premature ejaculation after oral administration on-demand.
The investigators hypothesized that newly-developed DA-8031 would effect in delaying ejaculation in patients with premature ejaculation (PE).
Design:
Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPO administration |
| DA-8031 dose 1 | Experimental | Drug: DA-8031PO administration |
| DA-8031 dose 2 | Experimental | Drug: DA-8031PO administration |
| DA-8031 dose 3 | Experimental | Drug: DA-8031PO administration |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male patients aged with premature ejaculation for more than 6 months.
- PEDT score ≥ 11
Key exclusion criteria (6 listed)
- IIEF-EF domain ≤ 21
- Serum Creatinine ≥ 2.5 mg/dl
- AST, ALT > 3*Upper limit of normal
- Subjects with hypotension(SBP/DBP<90/50mmHg) or uncontrolled hypertension(SBP/DBP>180/100mmHg)
- Subjects with chronic depression, psychiatric or schizophrenia,
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 |
|---|---|---|
| DA-8031 | Drug | DA-8031 dose 1, DA-8031 dose 2, DA-8031 dose 3 |
| PlaceboPlacebo of DA-8031, undistinguishable | Drug | Placebo |
Primary outcome
average IELT change
Time frame: From 0 week(baseline) to 8 week(end of treatment)
1 secondary outcome
PEP, PGI
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
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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.
Sung Won Lee contact
Sae Woong Kim principal investigator
Seoul St. Mary's Hospital
Du Geon Moon principal investigator
Korea University Guro Hospital
Nam-Cheol Park principal investigator
Pusan National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DA-8031 in people with Premature Ejaculation, run by Dong-A Pharmaceutical Co., Ltd. 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Aug 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung Won Lee (drswlee@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average IELT change (time frame: From 0 week(baseline) to 8 week(end of treatment)). 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 15 Aug 2013.