Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus

NCT00006133 | Completed

• 2 other identifiers: 199/15327UAB-SELENA
• Study Type: interventional
• Target: 970
• Locations: 1 country
• Sites: 17

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.

Conditions

Systemic Lupus Erythematosus

Keywords

arthritis & connective tissue diseases; immunologic disorders and infectious disorders; rare disease; systemic lupus erythematosus

Interventions

estradiol DRUG

ethinyl estradiol DRUG

medroxyprogesterone DRUG

norethindrone DRUG

Eligibility Criteria

• Age: 0 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• University of Alabama at Birmingham: collaborator

Study Sites (17)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

University of California Los Angeles

Los Angeles, California, 90095-6951, United States

Location

University of California-San Francisco

San Francisco, California, 94143, United States

Location

Pritzker School of Medicine

Chicago, Illinois, 60637, United States

Location

Louisiana State University School of Medicine

Shreveport, Louisiana, 71130-3932, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

University of Michigan Health Systems

Ann Arbor, Michigan, 48109, United States

Location

Hospital for Joint Diseases

New York, New York, 10003, United States

Location

Saint Luke's-Roosevelt Hospital Center

New York, New York, 10019, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Rheumatology Associates of Long Island

Port Jefferson Station, New York, 11776, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467-2490, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

University of Texas- Houston Medical School

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Arthritis; Connective Tissue Diseases; Immune System Diseases; Communicable Diseases; Rare Diseases

Interventions

Estradiol; Ethinyl Estradiol; Medroxyprogesterone; Norethindrone

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norpregnatrienes; Norpregnanes; Norsteroids; Estrogenic Steroids, Alkylated; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Norpregnenes

Study Officials

• Graciela S. Alarcon

  University of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 3, 2000
• First Posted: August 4, 2000
• Study Start: June 1, 2000
• Last Updated: June 24, 2005

Record last verified: 2003-12

Locations

US (17)