Pharmacokinetics and Safety of Transdermal Megestrol Acetate

• Status: Withdrawn
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Megestrol; Megestrol Acetate

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Known hypersensitivity to the transdermal vehicle.

• Taking any other medicine that would interfere with the Megace assay.

• Weight less than 10 kg.