Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus
Information source: National Center for Research Resources (NCRR)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Systemic Lupus Erythematosus
Intervention: estradiol (Drug); ethinyl estradiol (Drug); medroxyprogesterone (Drug); norethindrone (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
Graciela S. Alarcon, Study Chair, Affiliation: University of Alabama at Birmingham
Summary
OBJECTIVES: I. Determine the effect of oral contraceptives containing low-dose synthetic
estrogens and progestins on disease activity in premenopausal women with inactive, stable, or
moderate systemic lupus erythematosus (SLE).
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control
Detailed description:
PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.
Patients are stratified according to age/menopausal status (35 and under/premenopausal vs 50
and over/postmenopausal). Both strata are randomized to one of two treatment arms.
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
PROTOCOL ENTRY 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)
Locations and Contacts
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama 35294, United States
University of California Los Angeles, Los Angeles, California 90095-6951, United States
University of California-San Francisco, San Francisco, California 94143, United States
Pritzker School of Medicine, Chicago, Illinois 60637, United States
Louisiana State University School of Medicine, Shreveport, Louisiana 71130-3932, United States
Johns Hopkins University School of Medicine, Baltimore, Maryland 21205, United States
University of Michigan Health Systems, Ann Arbor, Michigan 48109, United States
Hospital for Joint Diseases, New York, New York 10003, United States
Hospital for Special Surgery, New York, New York 10021, United States
Montefiore Medical Center, Bronx, New York 10467-2490, United States
Rheumatology Associates of Long Island, Port Jefferson Station, New York 11776, United States
Saint Luke's-Roosevelt Hospital Center, New York, New York 10019, United States
University of North Carolina, Chapel Hill, North Carolina 27599, United States
University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
University of Pittsburgh, Pittsburgh, Pennsylvania 15260, United States
University of Texas- Houston Medical School, Houston, Texas 77030, United States
Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States
Additional Information
Starting date: June 2000
Last updated: June 23, 2005
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