Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus
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|ClinicalTrials.gov Identifier: NCT00006133|
Recruitment Status : Completed
First Posted : August 4, 2000
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: estradiol Drug: ethinyl estradiol Drug: medroxyprogesterone Drug: norethindrone||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||970 participants|
|Study Start Date :||June 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006133
|United States, Alabama|
|University of Alabama Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|University of California Los Angeles|
|Los Angeles, California, United States, 90095-6951|
|University of California-San Francisco|
|San Francisco, California, United States, 94143|
|United States, Illinois|
|Pritzker School of Medicine|
|Chicago, Illinois, United States, 60637|
|United States, Louisiana|
|Louisiana State University School of Medicine|
|Shreveport, Louisiana, United States, 71130-3932|
|United States, Maryland|
|Johns Hopkins University School of Medicine|
|Baltimore, Maryland, United States, 21205|
|United States, Michigan|
|University of Michigan Health Systems|
|Ann Arbor, Michigan, United States, 48109|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467-2490|
|Hospital for Joint Diseases|
|New York, New York, United States, 10003|
|Saint Luke's-Roosevelt Hospital Center|
|New York, New York, United States, 10019|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Rheumatology Associates of Long Island|
|Port Jefferson Station, New York, United States, 11776|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15260|
|United States, Texas|
|University of Texas- Houston Medical School|
|Houston, Texas, United States, 77030|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Study Chair:||Graciela S. Alarcon||University of Alabama at Birmingham|