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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
24 hour urine free cortisol level
Change in Cortisol level
Change in adenoma size
Secondary outcome measures
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%
0%
Study treatment Arm
Placebo
Elagolix 150 mg

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

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor
958 Previous Clinical Trials
502,383 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,464 Total Patients Enrolled
Alice C LevinePrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

Elagolix (GnRH Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05038878 — Phase 4
Cushing's Syndrome Research Study Groups: GnRH antagonist (Elagolix)
Cushing's Syndrome Clinical Trial 2023: Elagolix Highlights & Side Effects. Trial Name: NCT05038878 — Phase 4
Elagolix (GnRH Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05038878 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims does this clinical trial hope to achieve?

"This clinical trial, which will be assessed at baseline and again 6 months later, seeks to measure 24-hour urine free cortisol levels. Other key objectives include the Beck's Depression Scale (which is scored from 1 to 40+ indicating severity of depression), The Cushing's Quality of Life Questionnaire (scored 0-100 with higher scores representing better quality of life) and State Trait Anxiety Inventory (STAI; range 6-24 where higher numbers signify greater anxiety)."

Answered by AI

Is access to this research open for those in need of its benefits?

"As indexed on clinicaltrials.gov, this ongoing medical trial is still recruiting participants. The information was initially shared on July 6th 2021 and the details were last amended a month ago in August 2022."

Answered by AI

Is Elagolix likely to pose a hazard when taken as directed?

"As Elagolix is a Phase 4 drug, which has already been approved for market use, our team rates its safety as a 3 on the scale of 1 to 3."

Answered by AI

Has Elagolix undergone any previous research in the past?

"At present, there are 51 trials that have been activated to investigate Elagolix. 13 of these live clinical studies lie in Phase 3 and 1910 different sites are conducting the research. The majority of those locations are found within Chicago, Illinois."

Answered by AI

What therapeutic indications is Elagolix most commonly employed for?

"Elagolix can be employed to address menorrhagia, trigger ovulation, and shrink fibroid tumors."

Answered by AI

What is the participant intake of this research investigation?

"Affirmative. Per records hosted on clinicaltrials.gov, this medical experiment is presently recruiting patients; the study was first posted on July 6th 2021 and last revised on August 11th 2022. A dozen participants are required across 1 site in total."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women
Alice C. Levine 2021. "An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05038878.
All > Cushings Syndrome
~2 spots leftby Dec 2024
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