NCT01184105

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Plethora Solutions Ltd · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-08-18
• Last updated: 2016-08-10