Premature EjaculationPhase 2NCT01203202
Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation
A Phase 2 study testing Clomipramine in people with Premature Ejaculation, run by Symyoo at 2 sites in South Korea.
Trial summary
The purpose of this study is to evaluate whether PED-1 (15mg) and PED-2 (30mg) are tolerable and effective 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Sep 2010to Jan 2011
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent for subjects and partdners
- Men 20-65
- stable monogamous relation at least for 6 mn
- PEDT more than 9
- at least 6 Mn of premature ejaculation Hx
- IELT of =< 2 min in >= 75% of evaluable events during 4 week secreening period
Who cannot join
- Hx of medical or psychiartric illness
- erectile dysfunction (<21 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
2 sites in 1 country.
South Korea2 sites
Ewha University Mok-dong Hospital
Seoul
Seoul St. Marry's Hospital
Seoul
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped Clinical Study to Evaluate the Tolerability and to Determine the Adequate Dosage of PED-1 and PED-2 in Male Patients With Premature Ejaculation
The purpose of this study is to evaluate whether PED-1 (15mg) and PED-2 (30mg) are tolerable and effective in the treatment of premature ejaculation.
Read the detailed description
This study is to evaluate whether PED-1 and PED2 are tolerable and effective in the treatment of premature ejaculation. The patients will be randomized and allocated to three treatment groups into placebo, PED-1, and PED-2. The creteria for IELT for enrollment will be > or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT will be used. The patients ungone drug free baseline line period will take test drugs for 4 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, PED-2
15mg and 30mg on demand
| Study group | Role | What they receive |
|---|---|---|
| PED 0 | Placebo comparator | placebo Receives: Drug: Clomipramine |
| PED 1 | Experimental | PED-1 (clomipramine 15mg) Receives: Drug: Clomipramine |
| PED-2 | Experimental | PED-2 (Clomipramine 30mg) Receives: Drug: Clomipramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold cahnges of Intraviginal ejaculation latency time (IELT)
Measured: 4 weeks
Secondary outcomes (1)
Drug coitus interval time
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2011
- Study completionJan 2011
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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symyoo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Whan-Seok Choi, MD, PhD, Principal investigator, Seoul St. Marry's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203202
- Sponsor's protocol ID
- CTC PE 02
- Status last verified
- Oct 2012
- First submitted
- 14 Sep 2010
- 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 Clinical Study to Evaluate the Tolerability and to Determine the Adequate Dosage of PED-1 and PED-2 in Male Patients With Premature Ejaculation
- ClinicalTrials.gov ID
- NCT01203202
- Acronym / sponsor ID
- CTC PE 02
- Conditions
- Premature Ejaculation
- Keywords
- PE, IELT, DCIT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- SymyooIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 Sep 2010 (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 (15mg) and PED-2 (30mg) are tolerable and effective in the treatment of premature ejaculation.
Detailed description
This study is to evaluate whether PED-1 and PED2 are tolerable and effective in the treatment of premature ejaculation. The patients will be randomized and allocated to three treatment groups into placebo, PED-1, and PED-2. The creteria for IELT for enrollment will be > or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT will be used. The patients ungone drug free baseline line period will take test drugs for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PED 0 | Placebo comparator | Drug: Clomipramineplacebo |
| PED 1 | Experimental | Drug: ClomipraminePED-1 (clomipramine 15mg) |
| PED-2 | Experimental | Drug: ClomipraminePED-2 (Clomipramine 30mg) |
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 partdners
- Men 20-65
- stable monogamous relation at least for 6 mn
- PEDT more than 9
- at least 6 Mn of premature ejaculation Hx
Key exclusion criteria (4 listed)
- Hx of medical or psychiartric illness
- erectile dysfunction (<21 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-1, PED-215mg and 30mg on demand | Drug | PED 0, PED 1, PED-2 |
Primary outcome
Fold cahnges of Intraviginal ejaculation latency time (IELT)
Time frame: 4 weeks
1 secondary outcome
Drug coitus interval time
Time frame: 4 week
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.
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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.
Whan-Seok Choi, MD, PhD principal investigator
Seoul St. Marry's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clomipramine in people with Premature Ejaculation, run by Symyoo at 2 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 2 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 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?
Fold cahnges of Intraviginal ejaculation latency time (IELT) (time frame: 4 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.