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:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT00543166
Eligibility Criteria:
Inclusion Criteria:
1. Primary SS according to the American-European consensus criteria
2. General Fatigue ≥14 calculated from MFI-20 (Multiple fatigue inventory-20 questionnaire; the value was based on a pilot study of 239 members of the Finnish SS patient association)
3. subnormal serum S-DHEAS values (the reference values were calculated based on a pilot study of 81 healthy women and 57 healthy men).
Exclusion Criteria:
1. Age \<18 years or \>80 years
2. prisoner
3. individuals not able to give their informed consent
4. history of breast cancer
5. history of uterus cancer
6. history of prostatic cancer
7. history of stroke or prothrombotic coagulation disorders
8. pregnant or lactating women
9. fertile patients without adequate prevention
10. difficult acne
11. a significant liver disease
12. patients with changes in their systemic medication taken for SS during the previous three months 13) patients taking more than 10 mg prednisolone per day
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00543166
Study Brief:
Protocol Section:
NCT00543166