Healthy Volunteers Clinical Trial
Official title:
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
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
This was an open label, placebo and positive controlled, randomised, dose-ranging, cross-over
pilot study.
On each dosing day the subjects each received one dose of tetracaine (0.26 or 0.65 or 1.3mg),
or placebo, or Stud100® (which served as a positive control) on the glans penis The doses of
PET500 were applied in liquid spray form (260μl) at approximately the same time of the day as
the previous application to locations on the glans penis in a randomised fashion.
Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the
glans penis after the application of IMP.
The first two volunteers included in the trial piloted the sensitivity assessments prior to
the inclusion of all other subjects. Changes could be made to the assessment times on the
basis of the pilot data to ensure subsequent timings were relevant. However any such changes
were not to expose volunteers to more assessments than were specified in the study protocol.
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