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

This study has been completed.
Sponsor:
Information provided by:
Shionogi Inc.
ClinicalTrials.gov Identifier:
NCT01184105
First received: August 16, 2010
Last updated: September 13, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Premature Ejaculation
Drug: Intervention A
Drug: Intervention B
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Seven Days

Further study details as provided by Shionogi Inc.:

Primary Outcome Measures:
  • Safety of repeated application of PSD502 to the cervix and vaginal fornices in healthy female subjects. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
    Safety assessments consists of monitoring and recording of all adverse events and vital signs, electrocardiograms, physical examinations, and clinical laboratory tests


Secondary Outcome Measures:
  • Extent of systemic absorption of the active ingredients and their metabolites was determined by pharmacokinetic parameters [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: Yes ]
    Pharmacokinetic parameters: AUC0-t, AUC0-inf, AUCtau, Rc, Cmax, tmax, t½ and kel


Enrollment: 30
Study Start Date: September 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 (pre)
Active treatment or placebo
Drug: Intervention A
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)
Drug: Intervention B
A dose of placebo will consist of 6 sprays of the placebo spray applied topically to cervix (2 sprays) and vaginal fornices (4 sprays)
Experimental: Cohort 2 (post)
Active treatment or placebo
Drug: Intervention A
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)
Drug: Intervention B
A dose of placebo will consist of 6 sprays of the placebo spray applied topically to cervix (2 sprays) and vaginal fornices (4 sprays)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184105

Sponsors and Collaborators
Shionogi
Investigators
Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi
  More Information

No publications provided

Responsible Party: Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov Identifier: NCT01184105     History of Changes
Other Study ID Numbers: PSD502-PE-007
Study First Received: August 16, 2010
Last Updated: September 13, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014