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Evaluation of the Time Course of Adrenal Suppression and Adrenal Recovery After Ingestion of Megestrol Acetate


N/A
65 Years
80 Years
Not Enrolling
Both
Adrenal Insufficiency

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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 SciencesLittle Rock, Arkansas  72205