Premature EjaculationPhase 1NCT01183208
A Safety and Tolerability Study of Administration of PSD502
A Phase 1 study testing Intervention A, Intervention B and Intervention C in people with Premature Ejaculation, run by Plethora Solutions Ltd at 1 site in United Kingdom.
Trial summary
A Phase I, Single-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Pharmacokinetic and Safety Study to Evaluate Systemic Exposure and Local Vaginal Exposure to Lidocaine and Prilocaine and the Metabolites 2,6 DiMethylAlanine (2, 6, DMA) and O-Toluidine; and the Safety and Tolerability of PSD502 in… 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, Intervention B and Intervention C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2009to Feb 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 smear performed either during gynaecological examination at screening or documented in the 12 months prior to study entry
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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 this 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 an sexually transmitted disease, or is positive for hepatitis B, hepatitis C, or human immunodeficiency virus infection
- Safety testing: abnormalities at screening, in particular liver function tests, which 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 anaesthetics
- 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 90 days of screening
- Subject has any physical or psychological condition that would prevent them from undertaking the study procedures, including, but not limited to, the following:
- Uro-gynaecological disease or recent 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
- Subjects who refuse to allow their primary care physician to be informed of their participation
- Donation of blood or blood products within 90 days prior to dosing or at any time during the study, except as required by this protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Pharmacokinetic and Safety Study to Evaluate Systemic Exposure and Local Vaginal Exposure to Lidocaine and Prilocaine and the Metabolites 2,6 DiMethylAlanine (2, 6, DMA) and O-Toluidine; and the Safety and Tolerability of PSD502 in Female Healthy Volunteer Subjects Following Daily Application to the Vagina and Cervix for Seven Days With Three Different Doses of PSD502 or Placebo
A Phase I, Single-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Pharmacokinetic and Safety Study to Evaluate Systemic Exposure and Local Vaginal Exposure to Lidocaine and Prilocaine and the Metabolites 2,6 DiMethylAlanine (2, 6, DMA) and O-Toluidine; and the Safety and Tolerability of PSD502 in Female Healthy Volunteer Subjects Following Daily Application to the Vagina and Cervix for Seven Days With Three Different Doses of PSD502 or Placebo
Read the detailed description
The study drug is a metered-dose anaesthetic spray, which is being developed for the treatment of premature ejaculation (PE). The use of anaesthetic in topical creams has been well established, and there is a licensed topical anaesthetic cream in the market with the same active ingredients as the spray (eutectic mixture of local anaesthetics cream 5%, lidocaine \& prilocaine). The use of a cream does not result in the concentrated drug being in direct contact with the cells, unlike the spray.
Six clinical studies have already been carried out for the spray; two involved the recruitment of 556 PE patients with some being dosed for up to 1 year. 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 determine the effects of the drug on the whole body in females as well as local vaginal exposure to the spray. This study will be conducted in order to support a marketing application in the United States (US) at the request of the U.S. Food and Drug Administration.
- Conditions
- Premature Ejaculation
- Being tested
- Intervention A, Intervention B, Intervention C, Intervention D, Intervention E
- 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 3 mg will consist of 3 sprays of the 1 mg strength spray applied topically to cervix (1 spray) and vaginal fornices (2 sprays)
Intervention BDrug
A single dose of 30 mg will consist of 3 sprays of the 10 mg strength spray applied topically to cervix (1 spray) and vaginal fornices (2 sprays)
Intervention CDrug
A single dose of 150 mg will consist of 15 sprays of the 10 mg strength spray applied topically to cervix (5 sprays) and vaginal fornices (10 sprays)
Intervention DDrug
A dose of placebo will consist of 3 sprays of the placebo spray applied topically to cervix (1 spray) and vaginal fornices (2 sprays)
Intervention EDrug
A dose of placebo will consist of 15 sprays of the placebo spray applied topically to cervix (5 sprays) and vaginal fornices (10 sprays)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 active treatment and placebo | Experimental | Active treatment and placebo Receives: Drug: Intervention A; Drug: Intervention D |
| Cohort 2 - Active treatment and placebo | Experimental | Active treatment and placebo Receives: Drug: Intervention B; Drug: Intervention D |
| Cohort 3 Active Treatment and placebo | Experimental | Active treatment and placebo Receives: Drug: Intervention C; Drug: Intervention E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of adverse events, serious adverse events, findings from the examination of the cervix and vagina, vital signs, electrocardiogram data, hematology, and biochemistry parameters
Measured: Throughout the study
Secondary outcomes (2)
Pharmacokinetic parameters: AUC0-t, AUC0-inf, AUCtau, Rc, Cmax, tmax, t½ and kel
Measured: Days 1 through 7
Vaginal fluid analysis for active ingredients and metabolites
Measured: Days 2 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startDec 2009
- Primary completionFeb 2010
- Study completionFeb 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plethora Solutions Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bio-Kinetic Europe, Ltd., Omnicare Clinical Research
- Responsible party
- Sponsor
- Investigators
- Shionogi Clinical Trials Administrator Clinical Support Help Line, Study director, Shionogi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183208
- Sponsor's protocol ID
- PSD502-PE-006
- Status last verified
- Aug 2016
- First submitted
- 26 Jan 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-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Pharmacokinetic and Safety Study to Evaluate Systemic Exposure and Local Vaginal Exposure to Lidocaine and Prilocaine and the Metabolites 2,6 DiMethylAlanine (2, 6, DMA) and O-Toluidine; and the Safety and Tolerability of PSD502 in Female Healthy Volunteer Subjects Following Daily Application to the Vagina and Cervix for Seven Days With Three Different Doses of PSD502 or Placebo
- ClinicalTrials.gov ID
- NCT01183208
- Acronym / sponsor ID
- PSD502-PE-006
- Conditions
- Premature Ejaculation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Plethora Solutions LtdIndustry (pharma, biotech, devices)
- Collaborators
- Bio-Kinetic Europe, Ltd., Omnicare Clinical Research
- Study start
- Dec 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 17 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-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Pharmacokinetic and Safety Study to Evaluate Systemic Exposure and Local Vaginal Exposure to Lidocaine and Prilocaine and the Metabolites 2,6 DiMethylAlanine (2, 6, DMA) and O-Toluidine; and the Safety and Tolerability of PSD502 in Female Healthy Volunteer Subjects Following Daily Application to the Vagina and Cervix for Seven Days With Three Different Doses of PSD502 or Placebo
Detailed description
The study drug is a metered-dose anaesthetic spray, which is being developed for the treatment of premature ejaculation (PE). The use of anaesthetic in topical creams has been well established, and there is a licensed topical anaesthetic cream in the market with the same active ingredients as the spray (eutectic mixture of local anaesthetics cream 5%, lidocaine \& prilocaine). The use of a cream does not result in the concentrated drug being in direct contact with the cells, unlike the spray.
Six clinical studies have already been carried out for the spray; two involved the recruitment of 556 PE patients with some being dosed for up to 1 year. 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 determine the effects of the drug on the whole body in females as well as local vaginal exposure to the spray. This study will be conducted in order to support a marketing application in the United States (US) at the request of the U.S. Food and Drug Administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 active treatment and placebo | Experimental | Drug: Intervention A, Drug: Intervention DActive treatment and placebo |
| Cohort 2 - Active treatment and placebo | Experimental | Drug: Intervention B, Drug: Intervention DActive treatment and placebo |
| Cohort 3 Active Treatment and placebo | Experimental | Drug: Intervention C, Drug: Intervention EActive treatment and 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 (19 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 an sexually transmitted disease, or is positive for hepatitis B, hepatitis C, or human immunodeficiency virus infection
- Safety testing: abnormalities at screening, in particular liver function tests, which 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 3 mg will consist of 3 sprays of the 1 mg strength spray applied topically to cervix (1 spray) and vaginal fornices (2 sprays) | Drug | Cohort 1 active treatment and placebo |
| Intervention BA single dose of 30 mg will consist of 3 sprays of the 10 mg strength spray applied topically to cervix (1 spray) and vaginal fornices (2 sprays) | Drug | Cohort 2 - Active treatment and placebo |
| Intervention CA single dose of 150 mg will consist of 15 sprays of the 10 mg strength spray applied topically to cervix (5 sprays) and vaginal fornices (10 sprays) | Drug | Cohort 3 Active Treatment and placebo |
| Intervention DA dose of placebo will consist of 3 sprays of the placebo spray applied topically to cervix (1 spray) and vaginal fornices (2 sprays) | Drug | Cohort 1 active treatment and placebo, Cohort 2 - Active treatment and placebo |
| Intervention EA dose of placebo will consist of 15 sprays of the placebo spray applied topically to cervix (5 sprays) and vaginal fornices (10 sprays) | Drug | Cohort 3 Active Treatment and placebo |
Primary outcome
Evaluation of adverse events, serious adverse events, findings from the examination of the cervix and vagina, vital signs, electrocardiogram data, hematology, and biochemistry parameters
Time frame: Throughout the study
2 secondary outcomes
Pharmacokinetic parameters: AUC0-t, AUC0-inf, AUCtau, Rc, Cmax, tmax, t½ and kel
Time frame: Days 1 through 7
Vaginal fluid analysis for active ingredients and metabolites
Time frame: Days 2 and 5
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intervention A, Intervention B and Intervention C in people with Premature Ejaculation, run by Plethora Solutions Ltd at 1 site in United Kingdom.
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 19 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.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. 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?
Evaluation of adverse events, serious adverse events, findings from the examination of the cervix and vagina, vital signs, electrocardiogram data, hematology, and biochemistry parameters (time frame: Throughout the study). 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.