The purpose of this research study is to determine if treatment with Elagolix will improve body weight, waist circumference, muscle strength, cortisol secretion, blood glucose, cholesterol, and bone quality as well as mood and quality of life in a female patient with mild hypercortisolism from adrenal overproduction of cortisol. Many people with adrenal nodules, or non-cancerous growths in the adrenal glands, have mildly elevated cortisol levels. Cortisol is a hormone normally made by the adrenal glands. It is increasingly being recognized that even mild elevations in cortisol levels can negatively impact blood glucose levels, serum cholesterol levels, weight and other metabolic parameters. This can lead to an increase in risk for cardiovascular disease. The study team is trying to determine if the medication Elagolix might be an effective treatment for post-menopausal females with mild hypercortisolism. Elagolix is a medication used to treat a medical condition called endometriosis by decreasing the body's production of sex hormones. Growth of adrenal adenomas is thought to be driven by such sex hormones. Therefore, by decreasing production of these hormones, the study team hopes to treat hypercortisolism caused by adrenal adenomas.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Patients will be given Elagolix 200 mg orally twice daily for a total of 6 months
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Number of Participants With Change in Cortisol Level
Cortisol level after dexamethasone suppression test which measures whether adrenocorticotrophic hormone (ACTH) secretion by the pituitary can be suppressed. Number of participants with interval improvement and normalization of late-night salivary results after 6 months of treatment.
Time frame: baseline and 6 months
Change in Cortisol Level
Cortisol level after dexamethasone suppression test which measures whether adrenocorticotrophic hormone (ACTH) secretion by the pituitary can be suppressed. Cortisol secretion as reported below by assessment of pre-treatment and post-treatment of late-night salivary cortisol levels (normal midnight values: \<0.010 - 0.090)
Time frame: baseline and 6 months
Number of Participants With Change in 24 Hour Urine Free Cortisol Level
24 hour urine free cortisol measurements. The cortisol urine test measures the level of cortisol in the urine. Cortisol is a glucocorticoid (steroid) hormone produced by the adrenal gland. Number of participants with improvement in 24-hour urinary free cortisol after treatment (normal 24-hr urinary cortisol is between 6 - 42 ug/24 hr).
Time frame: Baseline and 6 months
24 Hour Urine Free Cortisol Level
24 hour urine free cortisol measurements. The cortisol urine test measures the level of cortisol in the urine. Cortisol is a glucocorticoid (steroid) hormone produced by the adrenal gland. Cortisol secretion as reported below by assessment of pre-treatment and post-treatment of 24-hour urinary cortisol levels (normal 24-hr urinary cortisol is between 6 - 42 ug/24 hr).
Time frame: Baseline and 6 months
Number of Participants With Change in Adenoma Size as Compared to Baseline
All patients will have baseline imaging (CT or MRI) within 6 months to start of treatment and then will have repeat imaging with CT abdomen without contrast at 6 months to determine the effect of elagolix treatment on adrenal adenoma size and imaging characteristics. The images will be reviewed by a dedicated adrenal radiologist for consistency.
Time frame: Baseline and 6 months
Change in Adenoma Size as Compared to Baseline
All patients will have baseline imaging (CT or MRI) within 6 months to start of treatment and then will have repeat imaging with CT abdomen without contrast at 6 months to determine the effect of elagolix treatment on adrenal adenoma size and imaging characteristics. The images will be reviewed by a dedicated adrenal radiologist for consistency.
Time frame: Baseline and 6 months
Change in Body Weight as Compared to Baseline
Mean percent change in body weight is measured in kilograms at 6 months compared to baseline
Time frame: baseline and 6 months
Change in Body Weight for Those Participants Who Lost Weight
Mean percent change in body weight is measured in kilograms at 6 months compared to baseline
Time frame: baseline and 6 months
Trunk Fat
Trunk Fat composition assessed by DEXA scans at baseline and at 6 months.
Time frame: baseline and 6 months
Preserved Glucose
fasting blood sugar
Time frame: baseline and 6 months
Number of Participants With Vertebral Fractures
Number of participants with vertebral fractures to measure rates will be assessed by lateral X-rays of thoracic and lumbar spine.
Time frame: baseline and 6 months
The Cushing's Quality of Life Questionnaire
The Cushing's Quality of Life Questionnaire is converted to a 0-100 scale in which 0 indicates the worse and 100 the best possible quality of life.
Time frame: baseline and 6 months
Beck's Depression Scale
Beck's Depression Scale is scored on a scale of 1 to 40, where the higher score indicates severe or extreme depression.
Time frame: baseline and 6 months
State Trait Anxiety Inventory (STAI)
The State Trait Anxiety Inventory gives a score range from 6-24 with the higher score indicating a higher level of anxiety.
Time frame: baseline and 6 months
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