A Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment of Premature Ejaculation

NCT01184105 | Completed Phase 1

• 1 other identifier: PSD502-PE-007
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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 mg PSD502 or placebo to the vagina and cervix for seven days

Conditions

Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Extent of systemic absorption of the active ingredients and their metabolites was determined by pharmacokinetic parameters

  Days 1 to 7

Study Arms (2)

Cohort 1 (pre)

EXPERIMENTAL

Active treatment or placebo

Drug: Intervention A; Drug: Intervention B

Cohort 2 (post)

EXPERIMENTAL

Active treatment or placebo

Drug: Intervention A; Drug: Intervention B

Interventions

Intervention A DRUG

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)

Cohort 1 (pre); Cohort 2 (post)

Intervention B DRUG

A dose of placebo will consist of 6 sprays of the placebo spray applied topically to cervix (2 sprays) and vaginal fornices (4 sprays)

Cohort 1 (pre); Cohort 2 (post)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Plethora Solutions Ltd: lead

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Shionogi Clinical Trials Administrator Clinical Support Help Line

  Shionogi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2010
• First Posted: August 18, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 10, 2016

Record last verified: 2015-09