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Vaginal Prednisone Administration for Prevention of Adrenal Crisis

NCT02689960 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-06-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

100mg prednisone suppository

vaginal administration of 100mg prednisone suppository (Rectodelt)

Sponsors & Collaborators

  • Wuerzburg University Hospital

    lead OTHER

Principal Investigators

  • Stefanie Hahner, MD, Prof. · University Hospital Wuerzburg

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-04-30
Completion
2017-06-01

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Entities

Diseases

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 NCT02689960 on ClinicalTrials.gov