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Study to Determine the Effect of a Newly Formulated Tetracaine Product PET500 on Penile Skin Sensation

NCT04247230 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-01-30

No results posted yet for this study

Summary

An open label, placebo and positive controlled, randomised, cross-over study in healthy male volunteers to determine the effect on penile skin sensation of a newly formulated tetracaine product PET500

Conditions

  • Healthy Volunteers

Interventions

DRUG

Tetracaine

Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.

OTHER

Matching placebo (PET500)

Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.

DRUG

STUD100

Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.

Sponsors & Collaborators

  • Richmond Pharmacology Limited

    collaborator INDUSTRY

  • Futura Medical Developments Ltd.

    lead INDUSTRY

Principal Investigators

  • Jorg Taubel, Dr · Richmond Pharmacology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-03
Primary Completion
2008-10-20
Completion
2009-02-23

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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 NCT04247230 on ClinicalTrials.gov