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NCT05038878 · ClinicalTrials.gov registry record · Phase 4
An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women
A Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT05038878: Clinical Trial Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05038878 is a Phase 4 study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05038878, a Phase 4 study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Elagolix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-07-06 |
| Est. Completion | 2022-06-24 |
| Phase | Phase 4 |
Why NCT05038878 stopped before completion
NCT05038878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Elagolix is the first listed.
NCT05038878 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05038878 about?
NCT05038878 is a clinical study titled "An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women". 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 adren...
What is the current status of trial NCT05038878?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2021-07-06. Estimated completion is 2022-06-24.
What interventions are being tested in trial NCT05038878?
The interventions under investigation include: Elagolix (DRUG).
Who is sponsoring clinical trial NCT05038878?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05038878's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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