Adrenal Insufficiency
Conditions
Keywords
megestrol acetate, adrenal insufficiency, adrenal suppression
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.
Interventions
DRUGmegestrol acetate
600 mg by mouth daily
Sponsors
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adrenal Insufficiency | stimulated acth stimulated cortisol levels weekly for 8 weeks or until adrenal insufficiency is encountered | 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 | weekly for up to 6 weeks | 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) |
Countries
United States
Participant flow
Recruitment details
Recruitment 4/04 to 7/04.
Participants by arm
| Arm | Count |
|---|---|
| Megestrol Acetate Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Megestrol Acetate |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age Continuous | 68 years STANDARD_DEVIATION 5.3 |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
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
Time frame: stimulated acth stimulated cortisol levels weekly for 8 weeks or until adrenal insufficiency is encountered
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Megestrol Acetate | Number of Participants With Adrenal Insufficiency | 7 participants |
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)
Time frame: weekly for up to 6 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Megestrol Acetate | Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function | participant 5 | 2 weeks |
| Megestrol Acetate | Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function | participant 6 | 2 weeks |
| Megestrol Acetate | Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function | participant 7 | 2 weeks |
| Megestrol Acetate | Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function | participant 1 | 6 weeks |
| Megestrol Acetate | Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function | participant 2 | 2 weeks |
| Megestrol Acetate | Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function | participant 3 | 2 weeks |
| Megestrol Acetate | Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function | participant 4 | 2 weeks |