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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| megace treatment | Experimental | Study subjects will be given 600mg of MA for oral ingestion per day for duration of 8 weeks. They will be monitored every week clinically for the development of adrenal insufficiency by review of symptoms, physical exam, body weight, pulse, and blood pressure. Subjects also will undergo biochemical evaluation of adrenal status every two weeks by measurement of serum electrolytes, serum cortisol, serum adrenocorticotropic hormone(ACTH) levels, and the adrenal response to a low dose ACTH (1µgm) stimulation test(see methods). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| megestrol acetate | Drug | 600 mg by mouth daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects will be excluded if they have a history of (H/O):
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| Name | Affiliation | Role |
|---|---|---|
| donald l bodenner | associate professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas For Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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Recruitment 4/04 to 7/04.
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| ID | Title | Description |
|---|---|---|
| FG000 | Megestrol Acetate | Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Megestrol Acetate | Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Apr 2011 | Number | participants | stimulated acth stimulated cortisol levels weekly for 8 weeks or until adrenal insufficiency is encountered |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Megestrol Acetate | Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks. |
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funding became an issue limiting the number of patients enrolled
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Donald Bodenner | University of Arkansas | 501-526-5710 | bodennerdonald@uams.edu |
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| ID | Term |
|---|---|
| D000309 | Adrenal Insufficiency |
| ID | Term |
|---|---|
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019290 | Megestrol Acetate |
| ID | Term |
|---|---|
| D008535 | Megestrol |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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) | Posted | Mar 2011 | Number | weeks | weekly for up to 6 weeks |
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| 0 |
| 7 |
| 0 |
| 7 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| participant 4 |
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| participant 5 |
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| participant 6 |
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| participant 7 |
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