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A Safety and Tolerability Study of Administration of PSD502

NCT01183208 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-08-10

No results posted yet for this study

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

Conditions

  • Premature Ejaculation

Interventions

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)

Sponsors & Collaborators

  • Bio-Kinetic Europe, Ltd.

    collaborator INDUSTRY

  • Omnicare Clinical Research

    collaborator INDUSTRY

  • Plethora Solutions Ltd

    lead INDUSTRY

Principal Investigators

  • Shionogi Clinical Trials Administrator Clinical Support Help Line · Shionogi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01183208 on ClinicalTrials.gov