Your session is about to expire
← Back to Search
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 belowSelect...
I can take pills and will follow the study's treatment plan.
Select...
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
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
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,245 Previous Clinical Trials
3,783,422 Total Patients Enrolled
Irina Bancos, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
480 Total Patients Enrolled
Share this study with friends
Copy Link
Messenger