Safety of Estrogens in Lupus: Hormone Replacement Therapy

May 1, 2013 updated by: NYU Langone Health

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1996

Study Completion

August 1, 2002

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (Estimate)

November 4, 1999

Study Record Updates

Last Update Posted (Estimate)

May 3, 2013

Last Update Submitted That Met QC Criteria

May 1, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01 AR42540 NIAMS-028A
  • U01AR042540 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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