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Patient Self-administration of Cortisol for Cortisol-responding Disorders in Men and Women Over the Age of 17

NCT03558971 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2430

Last updated 2018-06-15

No results posted yet for this study

Summary

Participants diagnosed as having fibromyalgia, osteoarthritis, and rheumatoid arthritis are to be brought to a minimum symptom state using a 3-week period during which they are to ingest modest doses of cortisol tablets with weekly lowered tapered doses. Thereafter, the participants are to be taught to self-administer cortisol tablets on the as-needed basis to maintain the minimum symptom state. For this, they are to ingest a smaller-dosage, 5-day tapered regimen of cortisol tablets to quench each reoccurring exacerbation of the disease at its earliest stage. Participants are limited to using less than the safe use limit of cortisol per month and are required to include a minimum of 10 days per month during which no cortisol was ingested.

Conditions

  • Rheumatic Diseases

Interventions

DRUG

Cortisol

Participants determine when to administer 5-day regimens of cortisol

Sponsors & Collaborators

  • Helen Foundation

    lead OTHER

Principal Investigators

  • Virgil I Stenberg, Ph.D. · University of North Dakota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-01
Primary Completion
2016-12-31
Completion
2016-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03558971 on ClinicalTrials.gov