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Pharmacokinetics and Safety of Transdermal Megestrol Acetate


Phase 4
N/A
N/A
Not Enrolling
Both
Cachexia

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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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

pharmacokinetics

Outcome Time Frame:

2 months

Safety Issue:

Yes

Principal Investigator

Andrew S Freiberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State University

Authority:

United States: Institutional Review Board

Study ID:

HM IRB# 18400

NCT ID:

NCT00163072

Start Date:

October 2005

Completion Date:

December 2012

Related Keywords:

  • Cachexia
  • transdermal
  • Megace
  • pharmacokinetics
  • Cachexia

Name

Location

Hershey Medical CenterHershey, Pennsylvania  17033