Search / Trial NCT00000419

Safety of Estrogens in Lupus: Hormone Replacement Therapy

Launched by NYU LANGONE HEALTH · Nov 3, 1999

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Trial Information

Current as of September 11, 2024

Terminated

Keywords

Sle Selena Estrogen Replacement Therapy (Ert) Postmenopause Osteoporosis Estrogens Steroids Progestin Placebo

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...

Gender

FEMALE

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

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

New York, New York, United States

Birmingham, Alabama, United States

Los Angeles, California, United States

Chicago, Illinois, United States

Shreveport, Louisiana, United States

Baltimore, Maryland, United States

Ann Arbor, Michigan, United States

Bronx, New York, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Oklahoma City, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Houston, Texas, United States

Richmond, Virginia, United States

Milwaukee, Wisconsin, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0