NCT01183208

A Safety and Tolerability Study of Administration of PSD502

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Plethora Solutions Ltd · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Premature Ejaculation

Interventions

Type	Name	Description
DRUG	Intervention A	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)
DRUG	Intervention B	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)
DRUG	Intervention C	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)
DRUG	Intervention D	A dose of placebo will consist of 3 sprays of the placebo spray applied topically to cervix (1 spray) and vaginal fornices (2 sprays)
DRUG	Intervention E	A dose of placebo will consist of 15 sprays of the placebo spray applied topically to cervix (5 sprays) and vaginal fornices (10 sprays)

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2010-08-17
• Last updated: 2016-08-10

Locations

1 site across 1 country: United Kingdom