Premature EjaculationPhase 1NCT01184105
A Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment of Premature Ejaculation
A Phase 1 study testing Intervention A and Intervention B in people with Premature Ejaculation, run by Plethora Solutions Ltd.
Trial summary
A phase I, single-center, double-blind, randomized, placebo-controlled, safety and pharmacokinetic study to evaluate systemic and local vaginal exposure to lidocaine and prilocaine and the metabolites, 2,6-dimethylaniline (2,6-DMA) and o-toluidine, in female healthy volunteer subjects following daily application of 60… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Intervention A and Intervention B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Nov 2010
- Phase
- Phase 1
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female non-smokers aged 18 years old and over
- Willing and able to provide written informed consent
- Generally, in good health in the opinion of the investigator
- Subject must have a body mass index between 18 and 30 kg/m2, inclusive
- Willing and able to comply with all study procedures in the opinion of the investigator
- Negative Papanicolaou (Pap) smear performed during gynecological examination at screening (i.e., Pap smear result that reads negative for any intraepithelial lesions and reparative or reactive changes and with no sign or presence of infection [e.g., bacterial vaginosis, candida, bacterial flora, etc])
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- Negative drugs of abuse and cotinine test at screening
- Female subjects of child-bearing potential who are sexually active or become sexually active must be using a method of effective contraception from 14 days before screening and continue to use until the end of the study. If oral contraceptives are used, these must have been stable for a period of 3 months. If a barrier method is being used, this should be latex based and not polyurethane based
- Female subjects who are post-menopausal must have been post-menopausal >1 year and have confirmed elevated serum follicle stimulating hormone at screening
Who cannot join
- History of a significant medical condition that would preclude further study participation in the opinion of the investigator
- Currently taking, or has taken within the 2 weeks prior to screening, any concomitant medication that could confound interpretation of the safety or pharmacokinetic data on PSD502. Use of prescription medication within 14 days or over-the-counter products within 7 days prior to first dose
- Suffering from a sexually transmitted disease, or is positive for hepatitis B, hepatitis C, human papillomavirus, or human immunodeficiency virus infection
- Safety testing: abnormalities at screening, in particular liver function tests, that are indicative of a medical condition and that would preclude further participation in the opinion of the investigator
- Significant abnormality of the vaginal mucosa or cervix that would preclude interpretation of the examination of these areas or that could be worsened by use of PSD502
- History of alcohol or drug abuse within 1 year prior to screening
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- Known drug sensitivity to amide-type local anesthetics
- Unlikely to understand or be able to comply with study procedures, for any reason, in the opinion of the investigator
- History of glucose-6-phosphate dehydrogenase deficiency or use of medications that would increase susceptibility to methemoglobinemia (e.g., anti-malarial agents)
- Use of class I (e.g., mexiletine, tocainide) and III (e.g., amiodarone, sotalol) anti-arrhythmic drugs
- Subject has received an investigational (non-registered) drug within 60 days of screening
- Subjects having any physical or psychological condition that would prevent them from undertaking the study procedures, including but not limited to, the following:
- Uro-gynecological disease or recent genito-urinary surgery within 8 weeks of screening which would make intravaginal application or vaginal examination/colposcopy difficult or painful or
- Ongoing significant psychiatric disorder (e.g., bipolar disease, depression/anxiety disorder or schizophrenia)
- Subject has a clinically obvious vaginal infection, such as active vaginal Candida albicans (thrush), or other abnormal vaginal discharge
- Subjects who are pregnant or lactating
- Subjects should not be menstruating during the treatment phase
- Donation of blood or blood products within 60 days prior to dosing or at any time during the study, except as required by this protocol
About this study
Official title: A Phase I, Single-Center, Double-Blind, Randomized, Placebo-Controlled, Safety and Pharmacokinetic Study to Evaluate Systemic and Local Vaginal Exposure to Lidocaine and Prilocaine and the Metabolites, 2,6-Dimethylaniline (2,6-DMA) and O-Toluidine, in Female Healthy Volunteer Subjects Following Daily Application of 60 mg PSD502 or Placebo to the Vagina and Cervix for 7 Days
A phase I, single-center, double-blind, randomized, placebo-controlled, safety and pharmacokinetic study to evaluate systemic and local vaginal exposure to lidocaine and prilocaine and the metabolites, 2,6-dimethylaniline (2,6-DMA) and o-toluidine, in female healthy volunteer subjects following daily application of 60 mg PSD502 or placebo to the vagina and cervix for seven days
Read the detailed description
The study drug is a metered-dose anesthetic spray, which is being developed for the treatment of premature ejaculation (PE). The use of anesthetic in topical creams has been well established. The use of a cream does not result in the concentrated drug being in direct contact with the cells, unlike the spray.
Seven clinical studies have already been carried out for the spray in the development of PE. These studies have demonstrated a prolongation of intravaginal ejaculatory latency time and no safety concerns for male patients or their female partners. The partners of clinical study participants have been asked to report health changes during the studies. Reports of vaginal numbness were uncommon; however, effects of the transfer to a partner cannot be excluded. This study is being conducted to investigate in detail the systemic exposure to PSD502 spray in order to assess safety in the female partner. The dose level has been chosen because the total dose applied to the male glans penis is 30 mg, and thus it is potentially possible that his partner could be exposed to this dose. Therefore, the 60 mg dose was chosen to provide safety information with a higher margin of exposure.
- Conditions
- Premature Ejaculation
- Being tested
- Intervention A, Intervention B
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ADrug
A single dose of 60 mg will consist of 6 sprays of the 10 mg strength spray applied topically to cervix (2 sprays) and vaginal fornices (4 sprays)
Intervention BDrug
A dose of placebo will consist of 6 sprays of the placebo spray applied topically to cervix (2 sprays) and vaginal fornices (4 sprays)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (pre) | Experimental | Active treatment or placebo Receives: Drug: Intervention A; Drug: Intervention B |
| Cohort 2 (post) | Experimental | Active treatment or placebo Receives: Drug: Intervention A; Drug: Intervention B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of repeated application of PSD502 to the cervix and vaginal fornices in healthy female subjects.
Safety assessments consists of monitoring and recording of all adverse events and vital signs, electrocardiograms, physical examinations, and clinical laboratory tests
Measured: Days 1 to 7
Secondary outcomes (1)
Extent of systemic absorption of the active ingredients and their metabolites was determined by pharmacokinetic parameters
Pharmacokinetic parameters: AUC0-t, AUC0-inf, AUCtau, Rc, Cmax, tmax, t½ and kel
Measured: Days 1 to 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2010
- Study completionNov 2010
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plethora Solutions Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shionogi Clinical Trials Administrator Clinical Support Help Line, Study director, Shionogi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184105
- Sponsor's protocol ID
- PSD502-PE-007
- Status last verified
- Sep 2015
- First submitted
- 16 Aug 2010
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Double-Blind, Randomized, Placebo-Controlled, Safety and Pharmacokinetic Study to Evaluate Systemic and Local Vaginal Exposure to Lidocaine and Prilocaine and the Metabolites, 2,6-Dimethylaniline (2,6-DMA) and O-Toluidine, in Female Healthy Volunteer Subjects Following Daily Application of 60 mg PSD502 or Placebo to the Vagina and Cervix for 7 Days
- ClinicalTrials.gov ID
- NCT01184105
- Acronym / sponsor ID
- PSD502-PE-007
- Conditions
- Premature Ejaculation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Plethora Solutions LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 18 Aug 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.
A phase I, single-center, double-blind, randomized, placebo-controlled, safety and pharmacokinetic study to evaluate systemic and local vaginal exposure to lidocaine and prilocaine and the metabolites, 2,6-dimethylaniline (2,6-DMA) and o-toluidine, in female healthy volunteer subjects following daily application of 60 mg PSD502 or placebo to the vagina and cervix for seven days
Detailed description
The study drug is a metered-dose anesthetic spray, which is being developed for the treatment of premature ejaculation (PE). The use of anesthetic in topical creams has been well established. The use of a cream does not result in the concentrated drug being in direct contact with the cells, unlike the spray.
Seven clinical studies have already been carried out for the spray in the development of PE. These studies have demonstrated a prolongation of intravaginal ejaculatory latency time and no safety concerns for male patients or their female partners. The partners of clinical study participants have been asked to report health changes during the studies. Reports of vaginal numbness were uncommon; however, effects of the transfer to a partner cannot be excluded. This study is being conducted to investigate in detail the systemic exposure to PSD502 spray in order to assess safety in the female partner. The dose level has been chosen because the total dose applied to the male glans penis is 30 mg, and thus it is potentially possible that his partner could be exposed to this dose. Therefore, the 60 mg dose was chosen to provide safety information with a higher margin of exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (pre) | Experimental | Drug: Intervention A, Drug: Intervention BActive treatment or placebo |
| Cohort 2 (post) | Experimental | Drug: Intervention A, Drug: Intervention BActive treatment or placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female non-smokers aged 18 years old and over
- Willing and able to provide written informed consent
- Generally, in good health in the opinion of the investigator
- Subject must have a body mass index between 18 and 30 kg/m2, inclusive
- Willing and able to comply with all study procedures in the opinion of the investigator
Key exclusion criteria (18 listed)
- History of a significant medical condition that would preclude further study participation in the opinion of the investigator
- Currently taking, or has taken within the 2 weeks prior to screening, any concomitant medication that could confound interpretation of the safety or pharmacokinetic data on PSD502. Use of prescription medication within 14 days or over-the-counter products within 7 days prior to first dose
- Suffering from a sexually transmitted disease, or is positive for hepatitis B, hepatitis C, human papillomavirus, or human immunodeficiency virus infection
- Safety testing: abnormalities at screening, in particular liver function tests, that are indicative of a medical condition and that would preclude further participation in the opinion of the investigator
- Significant abnormality of the vaginal mucosa or cervix that would preclude interpretation of the examination of these areas or that could be worsened by use of PSD502
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 |
|---|---|---|
| Intervention AA single dose of 60 mg will consist of 6 sprays of the 10 mg strength spray applied topically to cervix (2 sprays) and vaginal fornices (4 sprays) | Drug | Cohort 1 (pre), Cohort 2 (post) |
| Intervention BA dose of placebo will consist of 6 sprays of the placebo spray applied topically to cervix (2 sprays) and vaginal fornices (4 sprays) | Drug | Cohort 1 (pre), Cohort 2 (post) |
Primary outcome
Safety of repeated application of PSD502 to the cervix and vaginal fornices in healthy female subjects.
Time frame: Days 1 to 7
Safety assessments consists of monitoring and recording of all adverse events and vital signs, electrocardiograms, physical examinations, and clinical laboratory tests
1 secondary outcome
Extent of systemic absorption of the active ingredients and their metabolites was determined by pharmacokinetic parameters
Time frame: Days 1 to 7
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 10 Aug 2016.
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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.
Shionogi Clinical Trials Administrator Clinical Support Help Line study director
Shionogi
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intervention A and Intervention B in people with Premature Ejaculation, run by Plethora Solutions Ltd.
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 9 inclusion and 18 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 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety of repeated application of PSD502 to the cervix and vaginal fornices in healthy female subjects. (time frame: Days 1 to 7). 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 10 Aug 2016.