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GnRH Antagonist

Elagolix for Cushing's Syndrome

Phase 4

Recruiting

Led By Alice C Levine

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Patients with osteoporosis that are not receiving treatment with either antiresorptive medications (bisphosphonates, denosumab) or anabolic agents (teriparitide, abaloparatide or romosozumab)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Drug Has Already Been Approved

Approved for 5 Other Conditions

Pivotal Trial

Summary

This trial is testing if Elagolix, a medication used to treat endometriosis, can also improve weight, waist circumference, muscle strength, cortisol secretion, blood glucose, cholesterol, and bone quality in post-menopausal women with mild hypercortisolism.

Who is the study for?

This trial is for postmenopausal women who have non-cancerous growths in their adrenal glands, leading to slightly high cortisol levels. They should not be on certain bone medications or show strong signs of Cushing's Syndrome like muscle weakness and skin changes.

What is being tested?

The study tests if Elagolix can improve weight, waist size, muscle strength, cortisol levels, blood sugar, cholesterol, bone health as well as mood and life quality in women with mild hypercortisolism from adrenal adenomas.

What are the potential side effects?

Elagolix may cause side effects such as hot flashes, headache, fatigue, insomnia and mood swings due to its action on hormone production. It might also affect liver enzymes and menstrual bleeding patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a post-menopausal woman with a small, benign-looking adrenal tumor.

Select...

I have osteoporosis and am not on medications like bisphosphonates or teriparatide.

Select...

I have not had a menstrual period for at least 12 months due to menopause.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

24 hour urine free cortisol level

Change in Cortisol level

Change in adenoma size

Secondary study objectives

Beck's Depression Scale

Body weight

State Trait Anxiety Inventory (STAI)

+4 more

Side effects data

From 2021 Phase 4 trial • 82 Patients • NCT03886220

13%

HEADACHE

11%

HOT FLUSH

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Elagolix 150 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: GnRH antagonist (Elagolix)Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Elagolix

FDA approved

0 / 3Eligibility criteria met