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Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate

Primary Purpose

Adrenal Insufficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
megestrol acetate
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Adrenal Insufficiency focused on measuring megestrol acetate, adrenal insufficiency, adrenal suppression

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Elderly males and females
  • Age 65-80 years
  • With stable (no history of urgent/ emergent care visits with health care provider/s in the preceding 2 months), medical conditions

Exclusion Criteria:

Subjects will be excluded if they have a history of (H/O):

  • Dementia
  • Adrenal disease
  • Thromboembolism
  • Diabetes mellitus
  • Liver disease
  • Electrolyte abnormalities; or
  • Vaginal bleeding
  • Hypertriglyceridemia
  • CAD with CHF
  • Unstable depression
  • Schizophrenia; and
  • Morbidly obese subjects.

Sites / Locations

  • University of Arkansas For Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

megace treatment

Arm Description

Study subjects will be given 600mg of MA for oral ingestion per day for duration of 8 weeks. They will be monitored every week clinically for the development of adrenal insufficiency by review of symptoms, physical exam, body weight, pulse, and blood pressure. Subjects also will undergo biochemical evaluation of adrenal status every two weeks by measurement of serum electrolytes, serum cortisol, serum adrenocorticotropic hormone(ACTH) levels, and the adrenal response to a low dose ACTH (1µgm) stimulation test(see methods).

Outcomes

Primary Outcome Measures

Number of Participants With Adrenal Insufficiency
Number of participants with adrenal insufficiency after treatment with megestrol acetate assessed by ACTH stimulated cortisol levels less than normal (21 ug/dl) measured weekly for 8 weeks or when adrenal insufficiency is clinically encountered
Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function
the number of weeks required for participants to recover from adrenal suppression as assessed by a normal ACTH stimulation test (cortisol level >21 mcg/dl)

Secondary Outcome Measures

Full Information

First Posted
December 13, 2007
Last Updated
July 27, 2011
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT00575029
Brief Title
Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate
Official Title
Evaluation of the Time Course of Adrenal Suppression and Adrenal Recovery After Ingestion of Megestrol Acetate
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Arkansas

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Megestrol Acetate (MA) is a progesterone-like hormone that has been utilized as a birth control agent, chemotherapeutic drug, and more recently, to induce appetite and weight gain in patients malnourished as a result of radiation therapy, chemotherapy, cystic fibrosis, AIDS, or dementia. The mechanism of MA-stimulated appetite and weight gain is unknown. Although only approved to combat weight loss associated with AIDS and cancer, MA is frequently prescribed for long periods of time to prevent or reverse weight loss in nursing home residents and in elderly patients with serious illnesses in the community. Little data is available to support this practice. Among its many properties, MA acts as a partial glucocorticoid agonist, and long term and short term use of MA may results in adrenal suppression. The rapidity of the onset of MA-induced adrenal suppression and the time course of resumption of normal adrenal function after discontinuation of MA is completely unknown. As a consequence, it is unclear whether MA can be given safely for short periods of time or whether glucocorticoid administration is necessary after abruptly stopping MA treatment. The increased use of MA in the frail elderly, where even partial adrenal insufficiency may pose a substantial risk of adrenal crisis after an illness, requires a clear understanding of these issues. To address these concerns, we will evaluate adrenal function before, during, and after MA administration in healthy volunteers between the ages of 60 and 85 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Insufficiency
Keywords
megestrol acetate, adrenal insufficiency, adrenal suppression

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
megace treatment
Arm Type
Experimental
Arm Description
Study subjects will be given 600mg of MA for oral ingestion per day for duration of 8 weeks. They will be monitored every week clinically for the development of adrenal insufficiency by review of symptoms, physical exam, body weight, pulse, and blood pressure. Subjects also will undergo biochemical evaluation of adrenal status every two weeks by measurement of serum electrolytes, serum cortisol, serum adrenocorticotropic hormone(ACTH) levels, and the adrenal response to a low dose ACTH (1µgm) stimulation test(see methods).
Intervention Type
Drug
Intervention Name(s)
megestrol acetate
Intervention Description
600 mg by mouth daily
Primary Outcome Measure Information:
Title
Number of Participants With Adrenal Insufficiency
Description
Number of participants with adrenal insufficiency after treatment with megestrol acetate assessed by ACTH stimulated cortisol levels less than normal (21 ug/dl) measured weekly for 8 weeks or when adrenal insufficiency is clinically encountered
Time Frame
stimulated acth stimulated cortisol levels weekly for 8 weeks or until adrenal insufficiency is encountered
Title
Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function
Description
the number of weeks required for participants to recover from adrenal suppression as assessed by a normal ACTH stimulation test (cortisol level >21 mcg/dl)
Time Frame
weekly for up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Elderly males and females Age 65-80 years With stable (no history of urgent/ emergent care visits with health care provider/s in the preceding 2 months), medical conditions Exclusion Criteria: Subjects will be excluded if they have a history of (H/O): Dementia Adrenal disease Thromboembolism Diabetes mellitus Liver disease Electrolyte abnormalities; or Vaginal bleeding Hypertriglyceridemia CAD with CHF Unstable depression Schizophrenia; and Morbidly obese subjects.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
donald l bodenner
Organizational Affiliation
associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas For Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

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Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate

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