Clinical trial NCT00000419: Safety of Estrogens in Lupus: Hormone Replacement Therapy
Official title: Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Hormone Replacement Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
SELENA
Estrogen Replacement Therapy (ERT)
Postmenopause
Osteoporosis
Estrogens
Steroids
Progestin
Placebo
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Office of Research on Women's Health (ORWH)
First posted: 1999-11-04
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Medical Center
state: Alabama
city: Los Angeles
country: United States
facility: UCLA Medical Center, Dept. of Rheumatology
state: California
city: Chicago
country: United States
facility: University of Chicago Pritzker School of Medicine
state: Illinois
city: Shreveport
country: United States
facility: Louisiana School of Medicine
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Ann Arbor
country: United States
facility: Univ. of Michigan Med. Ctr., Rheumatology Div.
state: Michigan
city: Bronx
country: United States
facility: Albert Einstein College of Medicine, Jacoby Hospital, Dept. of Rheumatology
state: New York
city: New York
country: United States
facility: Hospital for Joint Diseases
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Chapel Hill
country: United States
facility: UNC Medical Center, Dept. of Rheumatology
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Philadelphia
country: United States
facility: Univ. of Pennsylvania Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Univ. of Pittsburgh, Dept. of Rheumatology
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas Health Sciences Center
state: Texas
city: Richmond
country: United States
facility: Medical College of Virginia, Ambulatory Care Center
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Hospital for Joint Diseases, Department of Rheumatology
name: Jill Buyon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Hospital, Department of Rheumatology
name: Michelle Petri, M.D.
role: STUDY_DIRECTOR
References:
citation: Petri M, Buyon J, Kim M. Classification and definition of major flares in SLE clinical trials. Lupus. 1999;8(8):685-91. doi: 10.1191/096120399680411281.
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. doi: 10.1191/096120399680411308.
citation: Buyon JP. Clinical trials in systemic lupus erythematosus. Curr Rheumatol Rep. 2000 Feb;2(1):11-12. doi: 10.1007/s11926-996-0062-y. No abstract available.
citation: Buyon JP. Hormone replacement therapy in postmenopausal women with systemic lupus erythematosus. J Am Med Womens Assoc (1972). 1998 Winter;53(1):13-7.
citation: 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. doi: 10.1002/art.1780400831. No abstract available.
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.
citation: 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. doi: 10.7326/0003-4819-142-12_part_1-200506210-00004.