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Corticosteroid

Metyrapone for Mild Autonomous Cortisol Secretion

Phase 2

Recruiting

Led By Irina Bancos, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Ability to take oral medication and be willing to adhere to the study intervention regimen

Diagnosed with MACS: at least 2 abnormal post-dexamethasone cortisol results (1 mg post-dexamethasone cortisol > 1.8 mcg/d; or 8 mg post-dexamethasone cortisol > 1 mcg/dL) and historical dexamethasone suppression test results can be used if performed within 6 months prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 50 months

Awards & highlights

Study Summary

This trial is testing a drug to see if it's safe and helpful for people with a kind of hormone imbalance.

Who is the study for?

This trial is for adults with Mild Autonomous Cortisol Secretion (MACS), evidenced by specific cortisol test results. Participants must have certain conditions like obesity or hypertension, be able to take oral meds, and commit to the study's duration. Women of childbearing age should use effective contraception.Check my eligibility

What is being tested?

The trial is testing metyrapone's safety and effectiveness in treating MACS. It involves taking this oral medication and adhering to a treatment regimen while researchers monitor its impact on participants' health over time.See study design

What are the potential side effects?

Metyrapone can cause side effects such as nausea, dizziness, tiredness, stomach pain, increased blood pressure or skin rash. More serious but less common side effects might include adrenal insufficiency where the body doesn't produce enough steroid hormones.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can take pills and will follow the study's treatment plan.

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I have abnormal cortisol levels after a dexamethasone test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 50 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~50 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 50 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

Adverse Events

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mild Autonomous Cortisol Secretion (MACS) Open Label Phase and Optional Extension PhaseExperimental Treatment1 Intervention

Subjects diagnosed with Mild Autonomous Cortisol Secretion (MACS) will receive metyrapone for a 6 month treatment period (Open Label Phase) with the option to continue for an additional 30 months of metyrapone therapy. If a patient chooses to participate in the Optional Extension Phase they will continue to receive metyrapone therapy until Month 36. This is an additional 30 months of therapy after completion of the Open Label Phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metyrapone

2012

Completed Phase 3

~500

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,458 Total Patients Enrolled

Irina Bancos, MDPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

480 Total Patients Enrolled

Frequently Asked Questions

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

Has the FDA approved Mild Autonomous Cortisol Secretion (MACS) Open Label Phase and Optional Extension Phase?

"With evidence of safety but not efficacy, Mild Autonomous Cortisol Secretion (MACS) Open Label Phase and Optional Extension Phase received a rating of 2."

Answered by AI

How many individuals have enlisted to participate in this trial?

"Confirmed. The available information on clinicaltrials.gov suggests that the trial is actively seeking participants, having first been posted on October 1st 2023 and updated most recently on October 24th of the same year. 30 people are needed from a single location for this study to be successful."

Answered by AI

Are there any vacancies for this clinical trial still available?

"Affirmative. Data available on clinicaltrials.gov demonstrates that this medical trial, inaugurated on October 1st 2023, is currently enrolling patients. 30 individuals must be recruited to participate from one centre of study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metyrapone for Mild Autonomous Cortisol Secretion (MACS)

Irina Bancos 2023. "Metyrapone for Mild Autonomous Cortisol Secretion (MACS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06106295.