Vaginal Prednisone Administration for Prevention of Adrenal Crisis

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

Patients with chronic adrenal insufficiency need to adapt their glucocorticoid replacement dose in conditions of physical or psychological stress to prevent life threatening adrenal crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g. gastroenteritis, severe infectious disease), rapid and highly dosed administration of glucocorticoids is crucial. The study is conducted to offer female patients the possibility to perform efficient prednisone self-administration in emergency situations in a way of administration, which is easy to perform and accepted by the patients. Therefore, pharmacokinetics and safety of vaginal prednisone administration will be studied and compared to rectal administration.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuerzburg University Hospital
• Treatments: Epinephrine; Epinephryl borate; Prednisone; Racepinephrine

Criteria

Inclusion Criteria:

• Female patients with chronic primary adrenal insufficiency due to autoimmune adrenalitis or bilateral adrenalectomy (disease duration at least 6 months)

• Age ≥ 18 years

• Patient´s written informed consent

• Ability to comply with the protocol procedures

• Established stable replacement therapy, no anticipated change in medication

• Negative pregnancy test and contraception (besides oral contraceptive pill) in pre-menopausal females

Exclusion Criteria:

• Diabetes mellitus

• Infectious disease with fever at time of investigation

• Known intolerance to the study drug or constituents

• Oral contraception

• Pregnancy or breast feeding

• Renal failure (creatinine >2.5 ULN)

• Disposition to vaginal mycosis (requiring treatment in the last 6 months or of necessity >2 antimycotic therapies/year)

• Recurrent urinary tract infections (of necessity >2 antibiosis therapies/year)