Safety of Estrogens in Lupus: Hormone Replacement Therapy

• Status: Terminated
• Trial end date: 2002-08-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); Office of Research on Women's Health (ORWH)
• Treatments: Estrogens; Estrogens, Conjugated (USP); Hormones; Medroxyprogesterone Acetate

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