Safety of Estrogens in Lupus: Hormone Replacement Therapy

Systemic Lupus Erythematosus Clinical Trial

Official title:

Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Hormone Replacement Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00000419
• Other study ID #: U01 AR42540 NIAMS-028A
• Secondary ID: U01AR042540
• Status: Terminated
• Phase: Phase 3
• First received: November 3, 1999
• Last updated: May 1, 2013
• Start date: April 1996
• Est. completion date: August 2002

Study information

• Verified date: May 2013
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 therapy (HRT) to women with SLE because of the widely held view that such treatment can activate SLE. This practice is based on the greater incidence of SLE in women than in men, biologic abnormalities of estrogen metabolism, murine models of lupus, several anecdotes of patients having disease flares while receiving exogenous hormones, and a single retrospective study in patients with preexisting renal disease. By contrast, recent retrospective studies suggest that the rate of flare is not significantly increased in patients taking HRT.

We will examine, in a multicenter, randomized, double-blind, placebo-controlled trial, the effect of hormonal replacement with conjugated estrogens on disease activity in postmenopausal women with SLE. We will recruit patients from clinics and private practices that include over 4,000 women with SLE, most belonging to minority groups.

We will give patients hormones for 1 year.

NOTE: This trial has been terminated as of August 2002 upon recommendation of the Data Safety Monitoring Board (DSMB), based on the findings of the WHI Trial. Study subjects have discontinued study drug but will continue followup visits to study doctors through May 2003

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 350
• Est. completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Premarin and Provera

Locations

Country	Name	City	State
United States	Univ. of Michigan Med. Ctr., Rheumatology Div.	Ann Arbor	Michigan
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	UAB Medical Center	Birmingham	Alabama
United States	Albert Einstein College of Medicine, Jacoby Hospital, Dept. of Rheumatology	Bronx	New York
United States	UNC Medical Center, Dept. of Rheumatology	Chapel Hill	North Carolina
United States	University of Chicago Pritzker School of Medicine	Chicago	Illinois
United States	University of Texas Health Sciences Center	Houston	Texas
United States	UCLA Medical Center, Dept. of Rheumatology	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Hospital for Joint Diseases	New York	New York
United States	Hospital for Special Surgery	New York	New York
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	Medical College of Virginia, Ambulatory Care Center	Richmond	Virginia
United States	Louisiana School of Medicine	Shreveport	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
New York University School of Medicine	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Office of Research on Women's Health (ORWH)

Country where clinical trial is conducted

United States, 

References & Publications (7)

Buyon JP, Dooley MA, Meyer WR, Petri M, Licciardi F. Recommendations for exogenous estrogen to prevent glucocorticoid-induced osteoporosis in premenopausal women with oligo- or amenorrhea: comment on the American College of Rheumatology recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Rheum. 1997 Aug;40(8):1548-9. — View Citation

Buyon JP, Petri MA, Kim MY, Kalunian KC, Grossman J, Hahn BH, Merrill JT, Sammaritano L, Lockshin M, Alarcón GS, Manzi S, Belmont HM, Askanase AD, Sigler L, Dooley MA, Von Feldt J, McCune WJ, Friedman A, Wachs J, Cronin M, Hearth-Holmes M, Tan M, Licciard — View Citation

Buyon JP, Wallace DJ. The endocrine system, use of exogenous estrogens, and the urogenital tract. In Dubois' Lupus Erythematosus, 6th edition. Wallace DJ, Hahn BH, eds. Philadelphia: Lippincott Williams & Wilkins, 2002; pp. 821-841.

Buyon JP. Clinical trials in systemic lupus erythematosus. Curr Rheumatol Rep. 2000 Feb;2(1):11-12. Review. — View Citation

Buyon JP. Hormone replacement therapy in postmenopausal women with systemic lupus erythematosus. J Am Med Womens Assoc. 1998 Winter;53(1):13-7. Review. — View Citation

Kim MY, Buyon JP, Petri M, Skovron ML, Shore RE. Equivalence trials in SLE research: issues to consider. Lupus. 1999;8(8):620-6. — View Citation

Petri M, Buyon J, Kim M. Classification and definition of major flares in SLE clinical trials. Lupus. 1999;8(8):685-91. — View Citation