Safety of Estrogens in Lupus: Birth Control Pills

• Status: Completed
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether women with systemic lupus erythematosus (SLE or lupus) can safely use estrogen. We will determine this by looking at the effects of oral contraceptives (birth control pills, also known as "the pill") on disease activity and severity in women with SLE. The results of the study will show whether it is safe for women with SLE to use the pill.

• 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: Contraceptive Agents; Contraceptives, Oral; Estrogens; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Norinyl

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