A Phase 2 interventional study of Placebo and PSD502 in Premature Ejaculation, sponsored by Plethora Solutions Ltd. Completed at 21 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-05.
Sponsored by Plethora Solutions Ltd · Phase 2, Interventional, and Treatment
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.
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.
106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
This study's enrollment of 121 is above the median of 84 across 89 interventional studies indexed under Premature Ejaculation.
Browse Premature Ejaculation studies →Plethora Solutions Ltd is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: PSD502
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).
Drug: Placebo
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.
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.
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
Time frame: Baseline and 4 week treatment period
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?'
Time frame: 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'.
Time frame: 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?'.
Time frame: 4 weeks post treatment
Intravaginal ejaculatory latency time
Change from baseline in intravaginal ejaculatory latency time
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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'
Time frame: 4 weeks post treatment
Plan to share: No
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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Plethora Solutions Ltd