Clinical trial NCT00575029: 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
Overall status: COMPLETED
Phase: NA
Conditions: Adrenal Insufficiency
Keywords: megestrol acetate
adrenal insufficiency
adrenal suppression
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2007-12-17
Enrollment: 7
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Number of Participants With Adrenal Insufficiency
timeFrame: stimulated acth stimulated cortisol levels weekly for 8 weeks or until adrenal insufficiency is encountered
measure: Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function
timeFrame: weekly for up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas For Medical Sciences
state: Arkansas
Study officials:
affiliation: associate professor
name: donald l bodenner
role: PRINCIPAL_INVESTIGATOR
References: