drugset / Trial / NCT03558971

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

NCT03558971

Phase 4 Completed 2430 enrolled Helen Foundation
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2000-01-01
Primary completion
2016-12-31
Completion
2016-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrocortisone Other / unclassified

Indications