Premature EjaculationPhase 2NCT00370981
Exploratory Study of Pagoclone in Men With Premature Ejaculation.
A Phase 2 study testing pagoclone in people with Premature Ejaculation, run by Endo USA Inc., a Keenova Therapeutics Company at 16 sites in United States.
Trial summary
The purpose of this study is to evaluate pagoclone in the treatment of premature ejaculation. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- pagoclone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 16 sitesUnited States
- Study dates
- Jul 2006to Oct 2006
- 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 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- A male regularly experiencing premature ejaculation
- 18 to 55 yrs old
- In a Stable relationship with one woman for at least 6 months
Who cannot join
None listed.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Urology Research Options
Aurora, Colorado, 80012
South Florida Medical Research
Aventura, Florida, 33180
Metrolina Urology Clinic
Charlotte, North Carolina, 28207
Urology Associates, PC
Denver, Colorado, 80210
Johnny B. Roy, MD Private Practice
Edmond, Oklahoma, 73034
Northeast Indiana Research, LLC
Fort Wayne, Indiana, 46825
AccuMed Research Associates
Garden City, New York, 11530
Urological Surgeons of Long Island, PC
Garden City, New York, 11530
Urology Centers of Alabama, PC
Homewood, Alabama, 35209
Mobley Research Center
Houston, Texas, 77024
Davis Clinic, PC
Indianapolis, Indiana, 46202
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
SD Uro-Research
San Diego, California, 92103
Regional Urology, LLC
Shreveport, Louisiana, 71106
Connecticut Clinical Research Center
Waterbury, Connecticut, 06708
Center for Urologic Research of WNY
Williamsville, New York, 14221
About this study
Official title: A Four-arm, Randomized, Double-blind, Parallel, Placebo-controlled Exploratory Study of Pagoclone 0.15mg, 0.30mg, and 0.60mg in Men With Primary Premature Ejaculation.
The purpose of this study is to evaluate pagoclone in the treatment of premature ejaculation.
Read the detailed description
The primary objective of this study is to evaluate the effect of 3 dose levels of pagoclone (0.15 mg, 0.30 mg, and 0.60 mg) versus placebo on intravaginal ejaculation latency time (IELT) male patients with primary premature ejaculation.
- Conditions
- Premature Ejaculation
- Being tested
- pagoclone
- Keywords
- investigational drug, ejaculation
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pagocloneDrug
| Study group | Role | What they receive |
|---|---|---|
| 0.15 mg | Experimental | Not described Receives: Drug: pagoclone |
| 0.30 mg | Experimental | Not described Receives: Drug: pagoclone |
| 0.60 mg | Experimental | Not described Receives: Drug: pagoclone |
| PBO | Placebo comparator | Not described Receives: Drug: pagoclone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravaginal ejaculation latency time (IELT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startJul 2006
- Primary completionJul 2006
- Study completionOct 2006
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
- 100 participants
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370981
- Sponsor's protocol ID
- IP456-040
- Status last verified
- Feb 2007
- First submitted
- 30 Aug 2006
- Last updated
- 27 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four-arm, Randomized, Double-blind, Parallel, Placebo-controlled Exploratory Study of Pagoclone 0.15mg, 0.30mg, and 0.60mg in Men With Primary Premature Ejaculation.
- ClinicalTrials.gov ID
- NCT00370981
- Acronym / sponsor ID
- IP456-040
- Conditions
- Premature Ejaculation
- Keywords
- investigational drug, ejaculation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 1 Sep 2006 (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 pagoclone in the treatment of premature ejaculation.
Detailed description
The primary objective of this study is to evaluate the effect of 3 dose levels of pagoclone (0.15 mg, 0.30 mg, and 0.60 mg) versus placebo on intravaginal ejaculation latency time (IELT) male patients with primary premature ejaculation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.15 mg | Experimental | Drug: pagoclone |
| 0.30 mg | Experimental | Drug: pagoclone |
| 0.60 mg | Experimental | Drug: pagoclone |
| PBO | Placebo comparator | Drug: pagoclone |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A male regularly experiencing premature ejaculation
- 18 to 55 yrs old
- In a Stable relationship with one woman for at least 6 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| pagoclone | Drug | 0.15 mg, 0.30 mg, 0.60 mg, PBO |
Primary outcome
Intravaginal ejaculation latency time (IELT)
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 27 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
16 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 pagoclone in people with Premature Ejaculation, run by Endo USA Inc., a Keenova Therapeutics Company at 16 sites in United States.
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 3 inclusion and 0 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 27 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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?
Intravaginal ejaculation latency time (IELT). 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 27 Dec 2013.