Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163072
Status:
WITHDRAWN
Last Update Posted:
2013-10-25
First Post:
2005-09-09
Brief Title:
Pharmacokinetics and Safety of Transdermal Megestrol Acetate
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Pharmacokinetics and Safety of Transdermal Megestrol Acetate
Status:
WITHDRAWN
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
Key Objectives Compare the pharmacokinetics of orally administered vs transdermal Megace and determine if there are any local side effects of the transdermal route
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None