Evaluation of the Time Course of Adrenal Suppression and Adrenal Recovery After Ingestion of Megestrol Acetate
65 Years
80 Years
Both
Adrenal Insufficiency
Trial Information
Evaluation of the Time Course of Adrenal Suppression and Adrenal Recovery After Ingestion of Megestrol Acetate
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Outcome Measure:
Number of Participants With Adrenal Insufficiency
Outcome 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
Outcome Time Frame:
stimulated acth stimulated cortisol levels weekly for 8 weeks or until adrenal insufficiency is encountered
Safety Issue:
Yes
Principal Investigator
donald l bodenner
Investigator Role:
Principal Investigator
Investigator Affiliation:
associate professor
Authority:
United States: Institutional Review Board
Study ID:
26835
NCT ID:
NCT00575029
Start Date:
April 2004
Completion Date:
December 2004
Related Keywords:
- Adrenal Insufficiency
- megestrol acetate
- adrenal insufficiency
- adrenal suppression
- Adrenal Insufficiency
- Addison Disease
Name | Location |
|---|---|
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
