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

NCT03558971 | Completed Phase 4 FDA Drug

• 1 other identifier: HF 101
• Study Type: interventional
• Target: 2,430
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cortisol

Outcome Measures

Primary Outcomes (1)

• Participant evaluation of disease symptom intensity

  Participants evaluate 50 symptoms for intensity using the 0 to 10 scale. 0 represents no disease intensity and 10 represents extreme maximum symptom intensity with the intermediate numbers defined as Mild I, Mild II, Mild III, Moderate I, Moderate II, Moderate III, Severe I, Severe II, Severe III for 2 through 9, respectively. The participant-determined disease intensity numbers of the 50 symptoms are added to obtain Total Score for each day.

  Participants determine Total Scores 7 days prior to cortisol initiation to obtain the average baseline Total Score. Participant Total Score change is plotted daily vs. time for study. Outcome: Total Score at 24 weeks vs. baseline.

Study Arms (1)

Patient self-administration of cortisol

EXPERIMENTAL

Intervention is patient self-administration of cortisol.

Drug: Cortisol

Interventions

Cortisol DRUG

Participants determine when to administer 5-day regimens of cortisol

Also known as: microdose therapy

Patient self-administration of cortisol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnoses of fibromyalgia, osteoarthritis, or rheumatoid arthritis -

You may not qualify if:

• Congestive heart failure, stomach ulceration, unstable diabetes, and bipolar disorder

Sponsors & Collaborators

• Helen Foundation: lead

Study Sites (1)

Helen Foundation Clinic

Apache Junction, Arizona, 85120, United States

Location

Related Publications (2)

• Stenberg VI, Fiechtner JJ, Rice JR, Miller DR, Johnson LK. Endocrine control of inflammation: rheumatoid arthritis double-blind, crossover clinical trial. Int J Clin Pharmacol Res. 1992;12(1):11-8.

  PMID: 1526694 BACKGROUND

• Irwin JB, Baldwin AL, Stenberg VI. General theory of inflammation: patient self-administration of hydrocortisone safely achieves superior control of hydrocortisone-responding disorders by matching dosage with symptom intensity. J Inflamm Res. 2019 Jun 13;12:161-166. doi: 10.2147/JIR.S195165. eCollection 2019.

  PMID: 31354330 DERIVED

MeSH Terms

Conditions

Rheumatic Diseases

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Virgil I Stenberg, Ph.D.

  University of North Dakota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants follow the same treatment protocol: First, the participants ingest a defined dosage, 3-week treatment of cortisol tablets to achieve a minimum symptom state. Second, after the first is complete, participants are trained to self-administer small-dosage, 5-day regimens of cortisol tablets to quench disease exacerbations to maintain the minimum symptom state.

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: June 15, 2018
• Study Start: January 1, 2000
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: June 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)