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 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT00544102
Eligibility Criteria:
* INCLUSION CRITERIA:
* Women 30-55 years of age.
* Must give written informed consent prior to entry in the protocol.
* Must fulfill at least 4 of the classification criteria for SLE as defined by the American College of Rheumatology.
* Diagnosis of SLE made 5 or more years prior to study participation.
EXCLUSION CRITERIA:
* Pregnancy within one year of study participation. Women of childbearing potential are required to have a negative pregnancy test at screening.
* Previous diagnosis of Type 1 or 2 diabetes mellitus.
* History of cerebrovascular accident (CVA: presence of irreversible or partially reversible motor and/or sensory deficits of sudden or recent onset on the basis of vascular occlusion or insufficiency, complete, incomplete or in evolution, persisting greater than 24 hours or lasting less than 24 hours with an anatomic correlate).
* Previous diagnosis of peripheral vascular disease (PVD: presence of arterial claudication \[pain in the muscles of the upper or lower extremities, induced by exercise and relieved by rest, with absent pulses and/or confirmed by Doppler flow studies and/or angiography\] lasting greater than 6 months and/or evidence of gangrene or significant tissue (digit or limb) loss not attributable to Raynaud s phenomenon).
* Therapy with pulse methylprednisolone or pulse prednisone within 4 weeks of study participation.
* Initiation or change in dosage of antilipemic agents within the preceding six weeks.
* Any active viral or bacterial infection
* Significant concurrent medical condition that, in the opinion of the Principal Investigator, could affect the patient s ability to tolerate or complete the study.
* Clinical coronary artery disease (CAD) defined as: history of MI and/or definite or classic angina (substernal chest discomfort provoked by exertion or emotion and relieved by rest or nitroglycerine), and/or conclusive evidence of MI on ECG
* Renal failure defined as hemodialysis-dependant, or calculated GFR less than or equal to 30 mL/minute (calculated by the MDRD 4 variable formula).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
55 Years
Study:
NCT00544102
Study Brief:
Protocol Section:
NCT00544102