Clinical trial NCT05038878: An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women
Official title: An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Mild Autonomous Cortisol Excess
Keywords: mild autonomous cortisol excess (MACE)
adrenal adenomas
postmenopausal women
GnRH antagonist
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2021-09-09
Enrollment: 4
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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:

  * Elevated 24 hr urine free cortisol (UFC) above the upper limit of normal (\>50 mcg/24 hours) in at least two complete 24-hour tests and/or
  * Late night salivary cortisol more than upper limit of normal in at least two tests and/or
  * an abnormal dexamethasone suppression defined as post 1mg dexamethasone suppression test serum cortisol concentration of \>1.8 mcg/ml
* 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:

Primary outcomes:
measure: Number of Participants With Change in Cortisol Level
timeFrame: baseline and 6 months
measure: Change in Cortisol Level
timeFrame: baseline and 6 months
measure: Number of Participants With Change in 24 Hour Urine Free Cortisol Level
timeFrame: Baseline and 6 months
measure: 24 Hour Urine Free Cortisol Level
timeFrame: Baseline and 6 months
measure: Number of Participants With Change in Adenoma Size as Compared to Baseline
timeFrame: Baseline and 6 months
measure: Change in Adenoma Size as Compared to Baseline
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in Body Weight as Compared to Baseline
timeFrame: baseline and 6 months
measure: Change in Body Weight for Those Participants Who Lost Weight
timeFrame: baseline and 6 months
measure: Trunk Fat
timeFrame: baseline and 6 months
measure: Preserved Glucose
timeFrame: baseline and 6 months
measure: Number of Participants With Vertebral Fractures
timeFrame: baseline and 6 months
measure: The Cushing's Quality of Life Questionnaire
timeFrame: baseline and 6 months
measure: Beck's Depression Scale
timeFrame: baseline and 6 months
measure: State Trait Anxiety Inventory (STAI)
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Alice C Levine
role: PRINCIPAL_INVESTIGATOR
References: