Pharmacokinetics and Safety of Transdermal Megestrol Acetate

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00163072
First received: September 9, 2005
Last updated: October 24, 2013
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Cachexia
Drug: transdermal Megace
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Safety of Transdermal Megestrol Acetate

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • pharmacokinetics [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • safety [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: October 2005
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: transdermal Megace
    oral vs transdermal levels
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00163072

Locations
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Andrew S Freiberg, MD Penn State University
  More Information

No publications provided

Responsible Party: Andrew S. Freiberg, MD, Penn State University
ClinicalTrials.gov Identifier: NCT00163072     History of Changes
Other Study ID Numbers: HM IRB# 18400
Study First Received: September 9, 2005
Last Updated: October 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
transdermal
Megace
pharmacokinetics

Additional relevant MeSH terms:
Cachexia
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Megestrol
Megestrol Acetate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Appetite Stimulants
Central Nervous System Stimulants
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 23, 2014