Safety of Estrogens in Lupus: Hormone Replacement Therapy
Launched by NYU LANGONE HEALTH · Nov 3, 1999
Trial Information
Current as of January 15, 2025
Terminated
Keywords
ClinConnect Summary
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
Trial Officials
Jill Buyon, M.D.
Principal Investigator
Hospital for Joint Diseases, Department of Rheumatology
Michelle Petri, M.D.
Study Director
Johns Hopkins Hospital, Department of Rheumatology
About Nyu Langone Health
NYU Langone Health is a premier academic medical center located in New York City, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, NYU Langone Health integrates cutting-edge scientific inquiry with patient-centered care, striving to develop new therapies and improve health outcomes across a wide range of medical conditions. The institution is dedicated to fostering collaboration among researchers, clinicians, and patients, ensuring rigorous adherence to ethical standards and regulatory guidelines in all clinical research initiatives. By leveraging its extensive resources and expertise, NYU Langone Health aims to contribute significantly to the advancement of medical knowledge and the enhancement of patient care.
Contacts
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
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