Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT02689960
Eligibility 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)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02689960
Study Brief:
Protocol Section:
NCT02689960