An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women

What Was Tested

In this phase 4 trial, researchers set out to test Elagolix (non-peptide).

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 had 1 arm (groups): 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.

The registry classes the interventions as drug.

Who Took Part

4 actual participants took part.

It was open to women only.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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:. Late night salivary cortisol more than upper limit of normal in at least two tests and/or. 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).

The full record lists 7 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Elagolix (non-peptide) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-07-06 with completion listed for 2022-06-24.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Change in Cortisol Level (time frame: baseline and 6 months). Change in Cortisol Level (time frame: baseline and 6 months). Number of Participants With Change in 24 Hour Urine Free Cortisol Level (time frame: Baseline and 6 months).

It also tracked 8 secondary outcomes, for example Change in Body Weight as Compared to Baseline, Change in Body Weight for Those Participants Who Lost Weight, Trunk Fat, Preserved Glucose, Number of Participants With Vertebral Fractures and The Cushing's Quality of Life Questionnaire.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Elagolix (non-peptide) in 4 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Elagolix (non-peptide) compound page, all human trials.