Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate

Adrenal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575029
• Other study ID #: 26835
• Status: Completed
• Phase: N/A
• First received: December 13, 2007
• Last updated: July 27, 2011
• Start date: April 2004
• Est. completion date: December 2004

Study information

• Verified date: July 2011
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Adrenal Insufficiency

Intervention

Drug:
• megestrol acetate
600 mg by mouth daily

Locations

Country	Name	City	State
United States	University of Arkansas For Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	stimulated acth stimulated cortisol levels weekly for 8 weeks or until adrenal insufficiency is encountered	Yes
Primary	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)	weekly for up to 6 weeks	No