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
All patients are followed at 1 year.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Graciela S. Alarcon
University of Alabama at Birmingham
United States: Federal Government
|University of Alabama Comprehensive Cancer Center||Birmingham, Alabama 35294|
|Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|Montefiore Medical Center||Bronx, New York 10467-2490|
|Louisiana State University School of Medicine||New Orleans, Louisiana 70112-2822|
|University of Texas- Houston Medical School||Houston, Texas 77030|
|University of Pittsburgh||Pittsburgh, Pennsylvania 15261|
|University of California Los Angeles||Los Angeles, California 90095-6951|
|University of California-San Francisco||San Francisco, California 94143|
|Pritzker School of Medicine||Chicago, Illinois 60637|
|Johns Hopkins University School of Medicine||Baltimore, Maryland 21205|
|University of Michigan Health Systems||Ann Arbor, Michigan 48109|
|Hospital for Joint Diseases||New York, New York 10003|
|Hospital for Special Surgery||New York, New York 10021|
|Saint Luke's-Roosevelt Hospital Center||New York, New York 10019|
|Rheumatology Associates of Long Island||Port Jefferson Station, New York 11776|
|University of North Carolina||Chapel Hill, North Carolina 27599|
|University of Pennsylvania||Philadelphia, Pennsylvania 19104|