Terminated

Phase 3
Age: 18Years - 85Years
FEMALE
ID00000419

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

Led by NYU Langone Health · Updated on 2013-05-03

350

Participants Needed

16

Research Sites

N/A

Total Duration

On this page

Sponsors

N

NYU Langone Health

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Safety of Estrogens in Lupus: Hormone Replacement Therapy

Who Can Participate

Age: 18Years - 85Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

Trial Site Locations

Total: 16 locations

1

UAB Medical Center

Birmingham, Alabama, United States, 35294

Status Unknown

2

UCLA Medical Center, Dept. of Rheumatology

Los Angeles, California, United States, 90024

Status Unknown

3

University of Chicago Pritzker School of Medicine

Chicago, Illinois, United States, 60637

Status Unknown

4

Louisiana School of Medicine

Shreveport, Louisiana, United States, 71130-3932

Status Unknown

5

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21205

Status Unknown

6

Univ. of Michigan Med. Ctr., Rheumatology Div.

Ann Arbor, Michigan, United States, 48109-0358

Status Unknown

7

Hospital for Joint Diseases

New York, New York, United States, 10003

Status Unknown

8

Hospital for Special Surgery

New York, New York, United States, 10021

Status Unknown

9

Albert Einstein College of Medicine, Jacoby Hospital, Dept. of Rheumatology

The Bronx, New York, United States, 10461

Status Unknown

10

UNC Medical Center, Dept. of Rheumatology

Chapel Hill, North Carolina, United States, 27599-7280

Status Unknown

11

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States, 73104

Status Unknown

12

Univ. of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States, 19104

Status Unknown

13

Univ. of Pittsburgh, Dept. of Rheumatology

Pittsburgh, Pennsylvania, United States, 15213

Status Unknown

14

University of Texas Health Sciences Center

Houston, Texas, United States, 77030

Status Unknown

15

Medical College of Virginia, Ambulatory Care Center

Richmond, Virginia, United States, 23219

Status Unknown

16

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

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.

J P Buyon, M A Dooley, W R Meyer...

https://pubmed.ncbi.nlm.nih.gov/9259444

The effect of combined estrogen and progesterone hormone replacement therapy on disease activity in systemic lupus erythematosus: a randomized trial.

Jill P Buyon, Michelle A Petri, Mimi Y Kim...

https://pubmed.ncbi.nlm.nih.gov/15968009