Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus
NCT ID: NCT00006133
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
970 participants
INTERVENTIONAL
2000-06-30
Brief Summary
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II. Determine the effect of hormone replacement therapy with conjugated estrogens and progestins on disease activity in postmenopausal women with inactive, stable, or moderate SLE.
Detailed Description
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Stratum 1 (Premenopausal/Oral contraceptives): Patients receive either oral ethinyl estradiol and norethindrone or placebo daily for 28 days beginning on the Sunday following the first day of the menstrual cycle.
Stratum 2 (Postmenopausal/Hormone replacement therapy): Patients receive either oral estradiol and medroxyprogesterone or placebo on days 1-12 monthly.
Treatment continues in both arms of both strata for a total of 13 courses in the absence of a severe disease flare-up or other complication that would preclude further study participation.
All patients are followed at 1 year.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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estradiol
ethinyl estradiol
medroxyprogesterone
norethindrone
Eligibility Criteria
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Inclusion Criteria
--Disease Characteristics--
Established systemic lupus erythematosus meeting American College of Rheumatology criteria
Inactive disease Systemic Lupus Erythematosus Activity Index (SLEDAI) score no greater than 4
No increase in score of more than 2 from baseline over the past 3 months
Receiving the equivalent of 5 mg or less of prednisone per day OR Stable/active disease SLEDAI score 5-12
No increase in score of more than 2 from baseline over the past 3 months
Prednisone dose up to 0.5 mg/kg/day for control of underlying disease allowed if stable dose for at least 3 weeks
No concurrent severe disease activity as defined by any of the following:
* Acute renal disease (i.e., rising creatinine levels, cellular sediment, or increasing proteinuria)
* Involvement of 3 or more organ systems requiring more than the equivalent of 0.5 mg/kg/day of prednisone
* Necessity of immediate hospitalization for symptom control
No presence of a high titer IgG, IgM, or IgA antiphospholipid antibodies (aPL) GPL and MPL no more than 40 APL no more than 50
No features of primary antiphospholipid antibody syndrome
--Prior/Concurrent Therapy--
Biologic therapy: Not specified
Chemotherapy: Not specified
Endocrine therapy: See Disease Characteristics
Radiotherapy: Not specified
Surgery: Prior hysterectomy allowed
--Patient Characteristics--
Age: 35 and under for oral contraceptive stratum (premenopausal) 50 and over for hormone replacement therapy stratum (postmenopausal)
Menopausal status:
* Premenopausal for oral contraceptive stratum
* Postmenopausal for hormone replacement therapy stratum
* Follicle-stimulating hormone greater than 40 mIU/mL OR Amenorrhea for 6 months
Performance status: See Disease Characteristics
Hematopoietic: Not specified
Hepatic:
* No hepatic dysfunction
* No tumors of the liver
Renal: See Disease Characteristics
Cardiovascular:
* No uncontrolled high blood pressure requiring frequent change in medication
* Concurrent hypertension controlled with stable medication allowed
* No history of spontaneous superficial or deep venous thrombosis or arterial thrombosis
* No prior myocardial infarction
* Oral contraceptive stratum: No angina No diastolic blood pressure greater than 90 mm Hg or systolic blood pressure greater than 140 mm Hg on 3 separate determinations
* Hormone replacement therapy stratum: No diastolic blood pressure greater than 95 mm Hg or systolic blood pressure greater than 145 mm Hg on 3 separate determinations
Pulmonary: No history of pulmonary embolus
Other:
* Not pregnant
* Oral contraceptive stratum: Negative pregnancy test Fertile patients must use effective barrier contraception
* No prior gynecologic malignancy or breast malignancy
* No undiagnosed vaginal bleeding
* No diabetes (present prior to use of glucocorticoids) requiring oral hypoglycemic medications or insulin
* No congenital hyperlipidemia
* No complicated migraines (i.e., associated with neurological sequelae)
0 Years
FEMALE
No
Sponsors
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University of Alabama at Birmingham
OTHER
National Center for Research Resources (NCRR)
NIH
Principal Investigators
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Graciela S. Alarcon
Role: STUDY_CHAIR
University of Alabama at Birmingham
Locations
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University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States
University of California Los Angeles
Los Angeles, California, United States
University of California-San Francisco
San Francisco, California, United States
Pritzker School of Medicine
Chicago, Illinois, United States
Louisiana State University School of Medicine
Shreveport, Louisiana, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
University of Michigan Health Systems
Ann Arbor, Michigan, United States
Hospital for Joint Diseases
New York, New York, United States
Saint Luke's-Roosevelt Hospital Center
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
Rheumatology Associates of Long Island
Port Jefferson Station, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas- Houston Medical School
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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UAB-SELENA
Identifier Type: -
Identifier Source: secondary_id
199/15327
Identifier Type: -
Identifier Source: org_study_id