Premature Ejaculation Clinical Trial
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
Verified date | September 2015 |
Source | Plethora Solutions Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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
Status | Completed |
Enrollment | 30 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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]) - 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 Exclusion Criteria: - 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 - 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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Plethora Solutions Ltd |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Days 1 to 7 | Yes |
Secondary | 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 | Days 1 to 7 | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02232425 -
IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)
|
Phase 2 | |
Completed |
NCT01439984 -
Trial of PED-1 in Male Patients With Premature Ejaculation
|
Phase 3 | |
Completed |
NCT01203202 -
Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation
|
Phase 2 | |
Completed |
NCT03942367 -
Evaluation of the Safety and Effectiveness of the vPatch Device
|
N/A | |
Recruiting |
NCT06425211 -
Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
|
N/A | |
Completed |
NCT02939495 -
The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy
|
Phase 4 | |
Completed |
NCT02572037 -
Research and Clinical Value of New Classification for Premature Ejaculation: Multi-Center Research
|
||
Recruiting |
NCT02581826 -
Safety and Efficacy of Silodosin in the Treatment of Premature Ejaculation
|
Phase 2 | |
Terminated |
NCT00983736 -
Study to Evaluate Efficacy and Safety in Male Subjects With Premature Ejaculation
|
Phase 3 | |
Completed |
NCT00556478 -
Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation
|
Phase 2/Phase 3 | |
Completed |
NCT00549211 -
A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
|
Phase 1 | |
Not yet recruiting |
NCT05556083 -
Sildenafil Added Effect in Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE)
|
Phase 2 | |
Completed |
NCT03304808 -
Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device: Star-Stop 3.0
|
N/A | |
Completed |
NCT00861484 -
Proof of Mechanism in ELT
|
Phase 1 | |
Completed |
NCT02984592 -
Effect of Exercise on Premature Ejaculation
|
N/A | |
Recruiting |
NCT02571101 -
A Phase 2 Study of On-demand Therapy With Clomipramine and Sildenafil Combination in Premature Ejaculation
|
Phase 2 | |
Completed |
NCT03174470 -
Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
|
N/A | |
Completed |
NCT02794454 -
A Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health
|
N/A | |
Completed |
NCT02297152 -
A New Treatment for Premature Ejaculation?
|
N/A | |
Not yet recruiting |
NCT00656552 -
Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation
|
Phase 0 |