NCT00163072

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 25, 2013

Status Verified

April 1, 2007

Enrollment Period

7.2 years

First QC Date

September 9, 2005

Last Update Submit

October 24, 2013

Conditions

Cachexia

Keywords

transdermalMegacepharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • pharmacokinetics

    2 months

  • safety

    2 months

Interventions

transdermal MegaceDRUG

oral vs transdermal levels

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Known hypersensitivity to the transdermal vehicle.
  • Taking any other medicine that would interfere with the Megace assay.
  • Weight less than 10 kg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Cachexia

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Study Officials

  • Andrew S Freiberg, MD

    Penn State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

October 1, 2005

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 25, 2013

Record last verified: 2007-04

Locations

US(1)