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Pharmacokinetics and Safety of Transdermal Megestrol Acetate

NCT00163072 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2013-10-25

No results posted yet for this study

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.

Conditions

  • Cachexia

Interventions

DRUG

transdermal Megace

oral vs transdermal levels

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Andrew S Freiberg, MD · Penn State University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00163072 on ClinicalTrials.gov