Status:
TERMINATED
Safety of Estrogens in Lupus: Hormone Replacement Therapy
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Office of Research on Women's Health (ORWH)
Conditions:
Systemic Lupus Erythematosus
Eligibility:
FEMALE
18-85 years
Phase:
PHASE3
Brief Summary
Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether postmenopausal women with systemic lupus erythematosus (SLE, or lupus) can safely use the hormone e...
Detailed Description
This study tests the effect of exogenous female hormones on disease activity and severity in women with systemic lupus erythematosus (SLE). Physicians generally do not prescribe hormone replacement th...
Eligibility Criteria
Inclusion Criteria:
- Female
- Unequivocal diagnosis of SLE
- Inactive disease or stable on 0.5 mg/kg/day or less of prednisone
- Chemical evidence of menopause or have stopped periods for at least 6 months
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 (HRT or OCP) for >1 month at any time after SLE diagnosis
- FSH <40
- Premenopausal myocardial infarction
Key Trial Info
Start Date :
April 1 1996
Trial Type :
INTERVENTIONAL
End Date :
August 1 2002
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00000419
Start Date
April 1 1996
End Date
August 1 2002
Last Update
May 3 2013
Active Locations (16)
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1
UAB Medical Center
Birmingham, Alabama, United States, 35294
2
UCLA Medical Center, Dept. of Rheumatology
Los Angeles, California, United States, 90024
3
University of Chicago Pritzker School of Medicine
Chicago, Illinois, United States, 60637
4
Louisiana School of Medicine
Shreveport, Louisiana, United States, 71130-3932