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Difficulty recruiting patients
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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnRH antagonist (Elagolix) | Experimental | Post-menopausal women with benign appearing adrenal adenomas, absence of clinical features of overt Cushing's signs or symptoms and MACE confirmed on either 24 hr urine free cortisol (UFC), late night salivary cortisol and/or abnormal dexamethasone suppression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elagolix | Drug | Patients will be given Elagolix 200 mg orally twice daily for a total of 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | 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). | 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight as Compared to Baseline | Mean percent change in body weight is measured in kilograms at 6 months compared to baseline | baseline and 6 months |
| Change in Body Weight for Those Participants Who Lost Weight |
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Inclusion Criteria:
Post-menopausal women that have incidentally found adrenal adenomas with benign appearing characteristics on imaging (<4 cm, non-contrast CT <10 HU and/or lipid rich and benign appearing on MRI)
Absence of anti-anabolic clinical features of overt Cushing's signs (proximal muscle weakness, >three ecchymoses, hyperpigmented striae) and 2 of 3 of the following:
Clinic status of cessation of menses for 12 mo in a previously cycling woman and reflecting complete or nearly complete permanent cessation of ovarian function and fertility (26).
Patients with osteoporosis that are not receiving treatment with either antiresorptive medications (bisphosphonates, denosumab) or anabolic agents (teriparitide, abaloparatide or romosozumab)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alice C Levine | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
Privacy
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| ID | Title | Description |
|---|---|---|
| FG000 | GnRH Antagonist (Elagolix) | Post-menopausal women with benign appearing adrenal adenomas, absence of clinical features of overt Cushing's signs or symptoms and MACE confirmed on either 24 hr urine free cortisol (UFC), late night salivary cortisol and/or abnormal dexamethasone suppression Elagolix: Patients will be given Elagolix 200 mg orally twice daily for a total of 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GnRH Antagonist (Elagolix) | Post-menopausal women with benign appearing adrenal adenomas, absence of clinical features of overt Cushing's signs or symptoms and MACE confirmed on either 24 hr urine free cortisol (UFC), late night salivary cortisol and/or abnormal dexamethasone suppression Elagolix: Patients will be given Elagolix 200 mg orally twice daily for a total of 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 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. | Posted | Count of Participants | Participants | baseline and 6 months |
|
6 months
There were no adverse events.
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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 | GnRH Antagonist (Elagolix) | Post-menopausal women with benign appearing adrenal adenomas, absence of clinical features of overt Cushing's signs or symptoms and MACE confirmed on either 24 hr urine free cortisol (UFC), late night salivary cortisol and/or abnormal dexamethasone suppression Elagolix: Patients will be given Elagolix 200 mg orally twice daily for a total of 6 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alice C. Levine | Icahn School of Medicine at Mount Sinai | (212) 241-3422 | alice.levine@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 2, 2018 | Dec 2, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 1, 2023 | Dec 2, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C539351 | elagolix |
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| 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. | Baseline and 6 months |
Mean percent change in body weight is measured in kilograms at 6 months compared to baseline
| baseline and 6 months |
| Trunk Fat | Trunk Fat composition assessed by DEXA scans at baseline and at 6 months. | baseline and 6 months |
| Preserved Glucose | fasting blood sugar | 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. | 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. | 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. | 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. | baseline and 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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) | Posted | Median | Full Range | ng/mL | baseline and 6 months |
|
|
|
| Primary | 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). | Posted | Count of Participants | Participants | Baseline and 6 months |
|
|
|
| Primary | 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). | Posted | Median | Full Range | ug/24 hour | Baseline and 6 months |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Baseline and 6 months |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | cm | Baseline and 6 months |
|
|
|
| Secondary | Change in Body Weight as Compared to Baseline | Mean percent change in body weight is measured in kilograms at 6 months compared to baseline | Posted | Mean | Standard Deviation | percent change in body weight | baseline and 6 months |
|
|
|
| Secondary | 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 | Data for participants who lost weight | Posted | Mean | Standard Deviation | percent change in body weight | baseline and 6 months |
|
|
|
| Secondary | Trunk Fat | Trunk Fat composition assessed by DEXA scans at baseline and at 6 months. | Data for participants who completed dexa scan at both timepoints | Posted | Mean | Standard Deviation | percent of total fat | baseline and 6 months |
|
|
|
| Secondary | Preserved Glucose | fasting blood sugar | Posted | Mean | Standard Deviation | mg/dL | baseline and 6 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | baseline and 6 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline and 6 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline and 6 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline and 6 months |
|
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| 6 months Salivary #2 |
|
| Title | Measurements |
|---|---|
|
| 6 months (CT) Left |
|