Premature EjaculationPhase 3NCT01439984
Trial of PED-1 in Male Patients With Premature Ejaculation
A Phase 3 study testing Clomipramine in people with Premature Ejaculation, run by Symyoo at 5 sites in South Korea.
Trial summary
The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the treatment of premature ejaculation. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Clomipramine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Sep 2011to Jun 2012
- Phase
- Phase 3
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent for subjects and partners
- Men 20-65 ages
- Stable monogamous relation at least for 6 mo
- Premature Ejaculation Diagnosis Tool (PEDT) more than 9
- At least 6 mo of premature ejaculation Hx
- IELT of =< 2 min in >= 75% of evaluable events during 4 week screening period
Who cannot join
- History of medical or psychiatric illness
- Erectile dysfunction (<21 International Index of Erectile Function-Erectile Function (IIEF-EF) domain score) or other forms of sexual dysfunction
- Partner sexual dysfunction
- Known hypersensitivity to clomipramine and contraindications for clomipramine
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do
National Health Insurance Corporation Ilsan Hospital
Goyang-si, Gyeonggi-do
Ewha Womans University Mokdong Hospital
Seoul
Seoul St.Marry's Hospital
Seoul
Uijeongbu St.Marry's Hospital
Uijeongbu-si, Gyeonggi-do
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped, Multi-center Clinical Study to Evaluate the Safety and Efficacy of PED-1 in Male Patients With Premature Ejaculation
The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the treatment of premature ejaculation.
Read the detailed description
This study is to evaluate whether PED-1 is effective than Placebo in the treatment of premature ejaculation. The patients will be randomized and allocated to two treatment groups into placebo, PED-1. The criteria for Intravaginal Ejaculation Latency Time(IELT) for enrollment will be > or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT(Premature Ejaculation Diagnosis Tool) will be used. The patients undergone drug free baseline period will take test drugs for 12 weeks.
- Conditions
- Premature Ejaculation
- Being tested
- Clomipramine
- Keywords
- PE, IELT, DCIT
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClomipramineDrug
Also called PED-1
Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| PED-1 | Experimental | PED-1 (Clomipramine 15 mg) Receives: Drug: Clomipramine |
| placebo | Placebo comparator | Not described Receives: Drug: Clomipramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravaginal ejaculation latency time (IELT)(seconds)
Measured: 12 weeks
Secondary outcomes (1)
Drug coitus interval time (hours)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2012
- Study completionJun 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symyoo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Whan-Seok Choi, MD,PhD, Principal investigator, Seoul St. Marry's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439984
- Sponsor's protocol ID
- CTC-PE-01
- Status last verified
- Oct 2012
- First submitted
- 18 Sep 2011
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped, Multi-center Clinical Study to Evaluate the Safety and Efficacy of PED-1 in Male Patients With Premature Ejaculation
- ClinicalTrials.gov ID
- NCT01439984
- Acronym / sponsor ID
- CTC-PE-01
- Conditions
- Premature Ejaculation
- Keywords
- PE, IELT, DCIT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- SymyooIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Sep 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.
The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the treatment of premature ejaculation.
Detailed description
This study is to evaluate whether PED-1 is effective than Placebo in the treatment of premature ejaculation. The patients will be randomized and allocated to two treatment groups into placebo, PED-1. The criteria for Intravaginal Ejaculation Latency Time(IELT) for enrollment will be > or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT(Premature Ejaculation Diagnosis Tool) will be used. The patients undergone drug free baseline period will take test drugs for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PED-1 | Experimental | Drug: ClomipraminePED-1 (Clomipramine 15 mg) |
| placebo | Placebo comparator | Drug: Clomipramine |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent for subjects and partners
- Men 20-65 ages
- Stable monogamous relation at least for 6 mo
- Premature Ejaculation Diagnosis Tool (PEDT) more than 9
- At least 6 mo of premature ejaculation Hx
Key exclusion criteria (4 listed)
- History of medical or psychiatric illness
- Erectile dysfunction (<21 International Index of Erectile Function-Erectile Function (IIEF-EF) domain score) or other forms of sexual dysfunction
- Partner sexual dysfunction
- Known hypersensitivity to clomipramine and contraindications for clomipramine
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 |
|---|---|---|
| ClomipramineAlso: PED-1Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks | Drug | PED-1, placebo |
Primary outcome
Intravaginal ejaculation latency time (IELT)(seconds)
Time frame: 12 weeks
1 secondary outcome
Drug coitus interval time (hours)
Time frame: 12 weeks
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 3 Oct 2012.
Related trials for Premature Ejaculation
Not yet recruiting
Male Pelvic Floor Muscle Rehabilitation Exercises
Erectile Dysfunction, Urinary Incontinence
RecruitingObservational study
Ejaculatory and Orgasmic Dysfunction Registry
Ejaculatory Dysfunction, Premature Ejaculation
RecruitingPhase 2
Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)
Premature Ejaculation
Not yet recruitingPhase 2
Evaluate the Efficacy and Safety of VV913 Capsules in the Treatment of PE
Premature Ejaculation
Active, not recruitingObservational study
Impact of Depression Severity on Sexual Dysfunction
Depression, Erectile Dysfunction
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.
Whan-Seok Choi, MD,PhD principal investigator
Seoul St. Marry's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clomipramine in people with Premature Ejaculation, run by Symyoo at 5 sites 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 6 inclusion and 4 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 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Intravaginal ejaculation latency time (IELT)(seconds) (time frame: 12 weeks). 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 3 Oct 2012.