Safety of Estrogens in Lupus: Hormone Replacement Therapy
Stopped early · Phase 3
Conditions studied: Systemic Lupus Erythematosus
In brief
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 estrogen. In this part of the study, we will look at the effects of estrogen replacement therapy on the activity and severity of disease in women with SLE.
Key facts
- Study ID
- NCT00000419
- Run by
- NYU Langone Health
- People needed
- 350
- Starts
- 1996-04-01
- Expected to finish
- 2002-08-01
- Last updated by the study team
- 2013-05-03
Who can join
Age: 18 and older, up to 85. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UAB Medical Center — Birmingham, Alabama, United States
- UCLA Medical Center, Dept. of Rheumatology — Los Angeles, California, United States
- University of Chicago Pritzker School of Medicine — Chicago, Illinois, United States
- Louisiana School of Medicine — Shreveport, Louisiana, United States
- Johns Hopkins Hospital — Baltimore, Maryland, United States
- Univ. of Michigan Med. Ctr., Rheumatology Div. — Ann Arbor, Michigan, United States
- Hospital for Joint Diseases — New York, New York, United States
- Hospital for Special Surgery — New York, New York, United States
- Albert Einstein College of Medicine, Jacoby Hospital, Dept. of Rheumatology — The Bronx, New York, United States
- UNC Medical Center, Dept. of Rheumatology — Chapel Hill, North Carolina, United States
- Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States
- Univ. of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
- Univ. of Pittsburgh, Dept. of Rheumatology — Pittsburgh, Pennsylvania, United States
- University of Texas Health Sciences Center — Houston, Texas, United States
- Medical College of Virginia, Ambulatory Care Center — Richmond, Virginia, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.