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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00000420
Eligibility Criteria:
Inclusion Criteria:
* Female
* Unequivocal diagnosis of SLE
* Inactive disease or be stable on 0.5 mg/kg/day or less of predisone
* Must be between 18 and 39 years old if non-smoker
* Must be between 18 and 35 years old if smoker
Exclusion Criteria:
* Blood pressure \>145/95 on three occasions
* Deep vein, arterial thrombosis or pulmonary embolus
* GPL \>40; MPL \>40; APL \>50; dRVVT \>37 sec
* APL antibody syndrome ever
* Gynecologic or breast cancer
* Hepatic dysfunction or liver tumors
* Diabetes mellitus (NOT due to steroids) with vascular disease
* Congenital hyperlipidemia
* Complicated migraine
* Severe disease activity (SLEDAI \>12)
* Increase in SLEDAI \>2 points in 3 months
* Unexplained vaginal bleeding
* Use of estrogen (OCP) for \>1 month at any time after SLE diagnosis
* Present pregnancy
* Angina or MI due to APS
* Age \>35 yrs. for smokers; \>39 yrs. for nonsmokers
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT00000420
Study Brief:
Protocol Section:
NCT00000420