Safety of Estrogens in Lupus: Hormone Replacement Therapy - Full Text View

Sponsors and Collaborators:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Office of Research on Women's Health (ORWH)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00000419

Purpose

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.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: Premarin and Provera	Phase III

MedlinePlus related topics: Hormone Replacement Therapy Lupus

Drug Information available for: Medroxyprogesterone Medroxyprogesterone 17-acetate Estrogens, conjugated

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Hormone Replacement Therapy

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Estimated Enrollment:	350
Study Start Date:	April 1996
Estimated Study Completion Date:	August 2002

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 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

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000419

Locations

United States, Alabama
UAB Medical Center
Birmingham, Alabama, United States, 35294
United States, California
UCLA Medical Center, Dept. of Rheumatology
Los Angeles, California, United States, 90024
United States, Illinois
University of Chicago Pritzker School of Medicine
Chicago, Illinois, United States, 60637
United States, Louisiana
Louisiana School of Medicine
Shreveport, Louisiana, United States, 71130-3932
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
United States, Michigan
Univ. of Michigan Med. Ctr., Rheumatology Div.
Ann Arbor, Michigan, United States, 48109-0358
United States, New York
Hospital for Joint Diseases
New York, New York, United States, 10003
Hospital for Special Surgery
New York, New York, United States, 10021
Albert Einstein College of Medicine, Jacoby Hospital, Dept. of Rheumatology
Bronx, New York, United States, 10461
United States, North Carolina
UNC Medical Center, Dept. of Rheumatology
Chapel Hill, North Carolina, United States, 27599-7280
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Univ. of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Univ. of Pittsburgh, Dept. of Rheumatology
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Health Sciences Center
Houston, Texas, United States, 77030
United States, Virginia
Medical College of Virginia, Ambulatory Care Center
Richmond, Virginia, United States, 23219
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Office of Research on Women's Health (ORWH)

Investigators

Principal Investigator:	Jill Buyon, M.D.	Hospital for Joint Diseases, Department of Rheumatology
Study Director:	Michelle Petri, M.D.	Johns Hopkins Hospital, Department of Rheumatology

More Information

Publications of Results:

Buyon JP, Petri MA, Kim MY, Kalunian KC, Grossman J, Hahn BH, Merrill JT, Sammaritano L, Lockshin M, Alarcon 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, Licciardi F. The effect of combined estrogen and progesterone hormone replacement therapy on disease activity in systemic lupus erythematosus: a randomized trial. Ann Intern Med. 2005 Jun 21;142(12 Pt 1):953-62. Summary for patients in: Ann Intern Med. 2005 Jun 21;142(12 Pt 1):I22.

Other Publications:

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

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

Buyon JP. Clinical trials in systemic lupus erythematosus. Curr Rheumatol Rep. 2000 Feb;2(1):11-12. Review. No abstract available.

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

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. No abstract available.

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.

Study ID Numbers:	U01 AR42540 NIAMS-028A
Study First Received:	November 3, 1999
Last Updated:	January 3, 2007
ClinicalTrials.gov Identifier:	NCT00000419
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

SLE
SELENA
Estrogen Replacement Therapy (ERT)
Postmenopause
Osteoporosis

Estrogens
Steroids
Progestin
Placebo

Study placed in the following topic categories:

Estrogens, Conjugated (USP)
Medroxyprogesterone 17-Acetate
Autoimmune Diseases
Lupus Erythematosus, Systemic

Connective Tissue Diseases
Osteoporosis
Medroxyprogesterone

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 13, 2009