Trial Information

Pharmacokinetics and Safety of Transdermal Megestrol Acetate

Study Population: Patients of any age who are already receiving oral Megace as an appetite
stimulant. Patients must have an indwelling IV catheter in order to draw drug levels.

Major Inclusion & Exclusion Criteria: Known hypersensitivity to the transdermal vehicle.
Taking any other medicine that would interfere with the Megace assay. Weight less than 10
kg.

Allocation to Groups: Patients will serve as their own controls.

Summary of Procedures: Patients will be on a stable dose of oral Megace. To determine the
steady state peak level and half-life for each patient, blood (2cc) will be drawn for a
level in clinic 3 hours after an oral dose, then daily for 1-3 days. Patients may then
resume their oral Megace, but must stop the medicine at least 5 half-lives prior to the
transdermal dose. The transdermal dose will be applied as a gel under a transparent patch
in clinic, and blood will be collected prior to, 10, 30, 60, 90, and 120 minutes, and 4
hours after the dose. The patch will be removed after the 4 hour blood level. The patient
will return the following day for a 24 hour level, and the patient will be examined briefly
for any local effects of the drug or vehicle, and then may resume the oral dose.

Major Risks & Discomforts: Patients will need to be in clinic for 3-5 separate days, one of
which will last at least 4 hours, for drug levels to be drawn. There may be mild skin
reaction to the transdermal vehicle or the Megace.