Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus
- Conditions
- Systemic Lupus Erythematosus
- Registration Number
- NCT00006133
- Lead Sponsor
- National Center for Research Resources (NCRR)
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 970
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Louisiana State University School of Medicine
🇺🇸Shreveport, Louisiana, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Pritzker School of Medicine
🇺🇸Chicago, Illinois, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Saint Luke's-Roosevelt Hospital Center
🇺🇸New York, New York, United States
Rheumatology Associates of Long Island
🇺🇸Port Jefferson Station, New York, United States
University of California-San Francisco
🇺🇸San Francisco, California, United States
University of Texas- Houston Medical School
🇺🇸Houston, Texas, United States
Hospital for Joint Diseases
🇺🇸New York, New York, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
University of Michigan Health Systems
🇺🇸Ann Arbor, Michigan, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States