Safety of Estrogens in Lupus: Hormone Replacement Therapy

This study has been terminated.
Sponsor:
Collaborators:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00000419
First received: November 3, 1999
Last updated: May 1, 2013
Last verified: May 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Hormone Replacement Therapy

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Albert Einstein College of Medicine, Jacoby Hospital, Dept. of Rheumatology
Bronx, New York, United States, 10461
Hospital for Special Surgery
New York, New York, United States, 10021
Hospital for Joint Diseases
New York, New York, United States, 10003
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
New York University School of Medicine
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:
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.

ClinicalTrials.gov Identifier: NCT00000419     History of Changes
Other Study ID Numbers: U01 AR42540 NIAMS-028A, U01AR042540
Study First Received: November 3, 1999
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
SLE
SELENA
Estrogen Replacement Therapy (ERT)
Postmenopause
Osteoporosis
Estrogens
Steroids
Progestin
Placebo

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014