Pharmacokinetics and Safety of Transdermal Megestrol Acetate

October 24, 2013 updated by: Milton S. Hershey Medical Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pharmacokinetics
Time Frame: 2 months
2 months
safety
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Andrew S Freiberg, MD, Penn State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

October 25, 2013

Last Update Submitted That Met QC Criteria

October 24, 2013

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM IRB# 18400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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