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
|Study Chair:||Graciela S. Alarcon||University of Alabama at Birmingham|