Premature EjaculationPhase 2NCT03578783
PSD502 in Subjects With Premature Ejaculation
A Phase 2 study testing PSD502 in people with Premature Ejaculation, run by Plethora Solutions Ltd at 21 sites in United States.
Trial summary
This study is being done to test the effect of PSD502 (the study medication) compared to placebo in subjects with premature ejaculation. PSD502 is a topical (applied to skin) anesthetic spray containing a mixture of two drugs called lidocaine and prilocaine that will be applied to the penis. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- PSD502
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 21 sitesUnited States
- Study dates
- 26 Dec 2018to 1 Dec 2021
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent.
- Male and aged 18 years and over.
- Diagnosed with PE according to the ISSM definition, that is, he ejaculates always or nearly always prior to or within about one minute of vaginal penetration; and is unable to delay ejaculation on all or nearly all vaginal penetrations; and experiences negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy.
- Subject has lifelong PE from the first sexual experience.
- Subject must be in a stable heterosexual and monogamous relationship of at least 3 months' duration with this partner.
- Subject has at least documented 3 sexual encounters, each separated by an interval of at least 24 hours, in the baseline period.
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- IELT ≤1 minute in all sexual encounters in the baseline period.
- The subject's partner must provide written informed consent, be aged 18 years or over and willing to comply with the study procedures.
- Subject indicates a level of Bother on Item 3 of the PEBEQ of either "moderately", "quite a bit" or "extremely" on all encounters during the baseline period.
- Subject registers a level of "bother" at a score of 4 or greater on an 11-point NRS scale at Screening to ensure that subjects not bothered by the quickness of their ejaculation are not entered into the baseline period.
Who cannot join
- Subject, or his sexual partner, has received an investigational (unapproved) drug within 30 days of Screening.
- Subject has erectile dysfunction, defined as an IIEF-5 score of 21, unless the low score is entirely related to PE symptoms in the opinion of the Investigator.
- The subject, or his sexual partner, has a physical or psychological condition that would prevent them from undertaking the study procedures, including, but not limited to, the following:
- Urological disease (e.g., prostatitis, urinary tract infection) or genitourinary surgery within 8 weeks of Screening.
- Ongoing significant psychiatric disorder (e.g., bipolar disease, depression / anxiety disorder or schizophrenia) not controlled by medication.
- Subject has safety testing abnormalities at the Screening Visit, in particular liver function tests or anemia, that are indicative of a medical condition that would preclude further participation in the opinion of the Investigator.
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- Subjects taking tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) or selective serotonin reuptake inhibitors (SSRIs), for indications other than PE, where the dose has been changed within 4 weeks of Screening or it is planned that the dose will change during the treatment period.
- Subject has received any treatment for PE e.g., anti-depressant therapy, local anesthetic spray, eutectic mixture of local anesthetics (EMLA®) cream, intra-cavernosal injection, tramadol or psychotherapy within 4 weeks of Screening
- Subject, or his sexual partner, has a current history of alcohol or drug abuse, in the opinion of the Investigator.
- The subject, or his sexual partner, is unlikely to understand or be able to comply with study procedures, for whatever reasons.
- Subject, or his sexual partner, has known drug sensitivity to amide-type local anesthetics.
- Subjects with pregnant partners.
- Subject with sexual partners of child-bearing potential and not using appropriate contraception (hormonal contraception or intra-uterine device [IUD]).
- Subject, or his sexual partner, has a history of glucose-6-phosphate dehydrogenase (G 6 PD) deficiency or currently using medications that would increase susceptibility to methemoglobinemia (e.g., anti-malarial agents) or has congenital or acquired methemoglobinemia, or is at risk of industrial exposure to agents causing methemoglobinemia.
- Subject, or his sexual partner, uses Class I (e.g., mexiletine, tocainide) or III (e.g., amiodarone, sotalol) anti-arrhythmic drugs, or cimetidine, beta blockers or local anesthetics.
- Subject has received PSD502 in a clinical study or has received Fortacin within 1 year of Screening.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Primary Care Research
Atlanta, Georgia, 30312
Midlantic Urology
Bala-Cynwyd, Pennsylvania, 19004
Achieve Clinical Research
Birmingham, Alabama, 35216
Boston Clinical Trials
Boston, Massachusetts, 02131
Imagine Research of Palm Beach County
Boynton Beach, Florida, 33435
Mens Health Boston
Chestnut Hill, Massachusetts, 02467
Accumed Research Associates
Garden City, New York, 11530
Jubilee Clinical Research, Inc
Las Vegas, Nevada, 89106
Georgia Clinical Research, Llc
Lawrenceville, Georgia, 30044
SunCoast Research
Miami, Florida, 33133
Suncoast Research Associates
Miami Lakes, Florida, 33014
Coastal Clinical Research
Mobile, Alabama, 36608
Manhattan Medical Research Practice
New York, New York, 10016
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601
M3 Wake Research, Inc
Raleigh, North Carolina, 27612
Advanced Clinical Research - Jordan Ridge Family Medicine
Salt Lake City, Utah, 84123
Skyline Urology
Sherman Oaks, California, 91411
Regional Urology, LLC
Shreveport, Louisiana, 71106
Chesapeake Urology Research Associates
Towson, Maryland, 21204
Advanced Clinical Research
West Jordan, Utah, 84088
About this study
Official title: A Pilot Multicenter, Randomized, Double-Blind Study Comparing The Proportion Of Responders to PSD502 and to Placebo Using the PEBEQ In Subjects With Premature Ejaculation
This study is being done to test the effect of PSD502 (the study medication) compared to placebo in subjects with premature ejaculation. PSD502 is a topical (applied to skin) anesthetic spray containing a mixture of two drugs called lidocaine and prilocaine that will be applied to the penis. Half of the subjects will receive PSD502 and half will receive placebo.
Read the detailed description
The study will assess whether the bothersome symptoms of premature ejaculation (PE) are helped when treated with PSD502 by answering questionnaires such as the 'Premature Ejaculation Bothersome Evaluation Questionnaire' (PEBEQ) and 'Index of Premature Ejaculation© (IPE) and some additional questions about premature ejaculation.
The study will also measure the effect of PSD502 on the Intravaginal Ejaculatory Latency Time (IELT). This is the time between when the penis enters the vagina and when the subject starts to ejaculate in the vagina.
Subjects are stratified based on whether they are circumcised or uncircumcised and within each stratified group subjects are randomized to PSD502 (lidocaine prilocaine spray) or placebo in a 1:1 ratio.
- Conditions
- Premature Ejaculation
- Being tested
- Placebo, PSD502
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration.
Study subjects should leave at least 24 hours between each dosing.
PSD502Drug
For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration.
Study subjects should leave at least 24 hours between each dosing.
| Study group | Role | What they receive |
|---|---|---|
| PSD502 | Experimental | PSD502 spray contains a eutectic-like mixture of lidocaine and prilocaine, and a propellant (norflurane) which also serves as a solvent. Each spray contains 7.5 mg lidocaine and 2.5 mg prilocaine. A single dose consists of 3 sprays applied to the glans penis. Receives: Drug: PSD502 |
| Placebo | Placebo comparator | The placebo is a metered dose spray, identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine (instead it contains PEG600 and Povidone). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between Baseline and 4 weeks : Success on the Premature Ejaculation Bothersome Evaluation Questionnaire PEBEQ Item 3 (event-specific bother)
Success is defined as having a 1-point or greater improvement between the mean response over the treatment period and the mean response during the baseline period
Measured: Baseline and 4 week treatment period
Secondary outcomes (10)
Patient Global Impression of Change
Patient-reported global impression of change in the quickness of their ejaculation. Subjects will be asked to provide a response to the question 'Compared to when you started the study, how would you describe any change in how quickly you ejaculate now?' on a 7-point scale of: 'A great deal better', 'Moderately better', 'A little better', 'About the same', 'A little worse', 'Moderately worse' and 'A great deal worse'. Subjects will also be asked to provide a 'Yes' or 'No' response to the question 'Was this a meaningful or important change for you?'
Measured: 4 weeks post treatment
Patient Global Impression of Severity
Change from baseline in patient-reported impression of severity of the quickness of their ejaculation.Subjects will be asked to answer the question 'Overall, how severe is the quickness of your ejaculation?' using a 5-point scale of 'Not Severe', 'Mildly Severe', 'Moderately Severe', 'Very Severe' and 'Extremely Severe'.
Measured: Baseline and 4 week treatment period
Patient Global Impression of Change-Bother
Patient-reported global impression of change in the bother resulting from the quickness of their ejaculation. Subjects will be asked to provide a response to the following question 'Compared to when you started the study, how would you describe any change in how much you are bothered by the quickness of your ejaculation now?' on a 7-point scale of: 'Bothered a great deal less', 'Bothered moderately less', 'Bothered a little less', 'Bothered about the same', 'Bothered a little worse', 'Bothered moderately worse' and 'Bothered a great deal worse'. Subjects will also be asked to provide a 'Yes' or 'No' response to the question 'Was this a meaningful or important change for you?'.
Measured: 4 weeks post treatment
Intravaginal ejaculatory latency time
Change from baseline in intravaginal ejaculatory latency time
Measured: Baseline and 4 week treatment period
Independent Ejaculation Quickness Item
Change from baseline in patient-reported impression of how quickly they ejaculated during each attempt of sexual intercourse
Measured: Baseline and 4 week treatment period
Index of Premature Ejaculation Control Domain Score
Change from baseline in the Index of Premature Ejaculation Control Domain Score. The domain is based on 4 items (score range 4-20). Low scores represent a worse value.
Measured: 4 weeks post treatment
Index of Premature Ejaculation Distress Domain Score
Change from baseline in the Index of Premature Ejaculation Distress Domain Score. The domain is based on two items (score range 2-10). Low scores represent a worse value.
Measured: 4 weeks post treatment
Index of Premature Ejaculation Satisfaction Domain Score
Change from baseline in the Index of Premature Ejaculation Satisfaction Domain Score. The domain is based on 4 items (score range 4-20). Low scores represent a worse value.
Measured: 4 weeks post treatment
Independent Numeric Response Scale Bother Item
Change from baseline in patient-reported assessment of bother during each attempt of sexual intercourse
Measured: Baseline and 4 week treatment period
Psychometric properties of the Premature Ejaculation Bothersome Evaluation Questionnaire Item 3 (event-specific bother)
Patient-reported impression of how bothered they were by how quickly they ejaculated during each attempt of sexual intercourse. Subjects will be asked to provide a response to the question 'How bothered were you by how quickly you ejaculated during the sexual intercourse you just engaged in?' on a 5-point scale of 'Not at All', 'A Little Bit', 'Moderately', 'Quite a Bit' and 'Extremely'
Measured: 4 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start26 Dec 2018
- Primary completion4 May 2021
- Study completion1 Dec 2021
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plethora Solutions Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jed Kaminetsky, MD, BA, Principal investigator, Manhattan Medical Research, 215 Lexington Avenue, 21st Floor, New York, NY 10016
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578783
- Sponsor's protocol ID
- PSD502-PE-008
- Status last verified
- Jun 2022
- First submitted
- 14 Jun 2018
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Multicenter, Randomized, Double-Blind Study Comparing The Proportion Of Responders to PSD502 and to Placebo Using the PEBEQ In Subjects With Premature Ejaculation
- ClinicalTrials.gov ID
- NCT03578783
- Acronym / sponsor ID
- PSD502-PE-008
- Conditions
- Premature Ejaculation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Plethora Solutions LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2018 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 6 Jul 2018 (actual)
- 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 being done to test the effect of PSD502 (the study medication) compared to placebo in subjects with premature ejaculation. PSD502 is a topical (applied to skin) anesthetic spray containing a mixture of two drugs called lidocaine and prilocaine that will be applied to the penis. Half of the subjects will receive PSD502 and half will receive placebo.
Detailed description
The study will assess whether the bothersome symptoms of premature ejaculation (PE) are helped when treated with PSD502 by answering questionnaires such as the 'Premature Ejaculation Bothersome Evaluation Questionnaire' (PEBEQ) and 'Index of Premature Ejaculation© (IPE) and some additional questions about premature ejaculation.
The study will also measure the effect of PSD502 on the Intravaginal Ejaculatory Latency Time (IELT). This is the time between when the penis enters the vagina and when the subject starts to ejaculate in the vagina.
Subjects are stratified based on whether they are circumcised or uncircumcised and within each stratified group subjects are randomized to PSD502 (lidocaine prilocaine spray) or placebo in a 1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSD502 | Experimental | Drug: PSD502PSD502 spray contains a eutectic-like mixture of lidocaine and prilocaine, and a propellant (norflurane) which also serves as a solvent. Each spray contains 7.5 mg lidocaine and 2.5 mg prilocaine. A single dose consists of 3 sprays applied to the glans penis. |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo is a metered dose spray, identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine (instead it contains PEG600 and Povidone). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willing and able to provide written informed consent.
- Male and aged 18 years and over.
- Diagnosed with PE according to the ISSM definition, that is, he ejaculates always or nearly always prior to or within about one minute of vaginal penetration; and is unable to delay ejaculation on all or nearly all vaginal penetrations; and experiences negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy.
- Subject has lifelong PE from the first sexual experience.
- Subject must be in a stable heterosexual and monogamous relationship of at least 3 months' duration with this partner.
Key exclusion criteria (16 listed)
- Subject, or his sexual partner, has received an investigational (unapproved) drug within 30 days of Screening.
- Subject has erectile dysfunction, defined as an IIEF-5 score of 21, unless the low score is entirely related to PE symptoms in the opinion of the Investigator.
- The subject, or his sexual partner, has a physical or psychological condition that would prevent them from undertaking the study procedures, including, but not limited to, the following:
- Subject has safety testing abnormalities at the Screening Visit, in particular liver function tests or anemia, that are indicative of a medical condition that would preclude further participation in the opinion of the Investigator.
- Subjects taking tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) or selective serotonin reuptake inhibitors (SSRIs), for indications other than PE, where the dose has been changed within 4 weeks of Screening or it is planned that the dose will change during the treatment period.
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 |
|---|---|---|
| PlaceboFor each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing. | Drug | Placebo |
| PSD502For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing. | Drug | PSD502 |
Primary outcome
Change between Baseline and 4 weeks : Success on the Premature Ejaculation Bothersome Evaluation Questionnaire PEBEQ Item 3 (event-specific bother)
Time frame: Baseline and 4 week treatment period
Success is defined as having a 1-point or greater improvement between the mean response over the treatment period and the mean response during the baseline period
10 secondary outcomes
Patient Global Impression of Change
Time frame: 4 weeks post treatment
Patient Global Impression of Severity
Time frame: Baseline and 4 week treatment period
Patient Global Impression of Change-Bother
Time frame: 4 weeks post treatment
Intravaginal ejaculatory latency time
Time frame: Baseline and 4 week treatment period
Independent Ejaculation Quickness Item
Time frame: Baseline and 4 week treatment period
Index of Premature Ejaculation Control Domain Score
Time frame: 4 weeks post treatment
Index of Premature Ejaculation Distress Domain Score
Time frame: 4 weeks post treatment
Index of Premature Ejaculation Satisfaction Domain Score
Time frame: 4 weeks post treatment
Independent Numeric Response Scale Bother Item
Time frame: Baseline and 4 week treatment period
Psychometric properties of the Premature Ejaculation Bothersome Evaluation Questionnaire Item 3 (event-specific bother)
Time frame: 4 weeks post treatment
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 5 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Jed Kaminetsky, MD, BA principal investigator
Manhattan Medical Research, 215 Lexington Avenue, 21st Floor, New York, NY 10016
21 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 PSD502 in people with Premature Ejaculation, run by Plethora Solutions Ltd at 21 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 10 inclusion and 16 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 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
Change between Baseline and 4 weeks : Success on the Premature Ejaculation Bothersome Evaluation Questionnaire PEBEQ Item 3 (event-specific bother) (time frame: Baseline and 4 week treatment period). 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 5 Jul 2022; AzTrials last refreshed its copy on 26 Oct 2026.