Pharmacokinetics and Safety of Transdermal Megestrol Acetate
Status:
Withdrawn
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
Rationale: Megestrol acetate (Megace®) is a progestin analog that is FDA approved for the
palliative treatment of breast and endometrial carcinoma. It is also commonly used as an
appetite stimulant, particularly in HIV and cancer patients with poor appetite from their
primary disease and/or their therapy. Megace is well absorbed orally, however, many patients,
particularly younger ones have difficulty taking oral medications. Transdermal progestins are
available and are FDA approved. For example, Ortho EvraTM is a transdermal contraceptive
patch containing an estrogen (ethinyl estradiol) and a progestin (norelgestromin).
Key Objectives: Compare the pharmacokinetics of orally administered vs. transdermal Megace
and determine if there are any local side effects of the transdermal route.