Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00006133
First received: August 3, 2000
Last updated: June 23, 2005
Last verified: December 2003
  Purpose

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 Intervention
Systemic Lupus Erythematosus
Drug: estradiol
Drug: ethinyl estradiol
Drug: medroxyprogesterone
Drug: norethindrone

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 970
Study Start Date: June 2000
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006133

Locations
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
Hospital for Special Surgery
New York, New York, United States, 10021
Saint Luke's-Roosevelt Hospital Center
New York, New York, United States, 10019
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
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Study Chair: Graciela S. Alarcon University of Alabama at Birmingham
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006133     History of Changes
Other Study ID Numbers: 199/15327, UAB-SELENA
Study First Received: August 3, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
arthritis & connective tissue diseases
immunologic disorders and infectious disorders
rare disease
systemic lupus erythematosus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Contraceptive Agents, Female
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Medroxyprogesterone
Medroxyprogesterone Acetate
Norethindrone
Polyestradiol phosphate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Male
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014