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

June 23, 2005 updated by: National Center for Research Resources (NCRR)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

970

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama Comprehensive Cancer Center
    • California
      • Los Angeles, California, United States, 90095-6951
        • University of California Los Angeles
      • San Francisco, California, United States, 94143
        • University of California-San Francisco
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Pritzker School of Medicine
    • Louisiana
      • Shreveport, Louisiana, United States, 71130-3932
        • Louisiana State University School of Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University School Of Medicine
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health Systems
    • New York
      • Bronx, New York, United States, 10467-2490
        • Montefiore Medical Center
      • New York, New York, United States, 10021
        • Hospital for Special Surgery
      • New York, New York, United States, 10003
        • Hospital for Joint Diseases
      • New York, New York, United States, 10019
        • Saint Luke's-Roosevelt Hospital Center
      • Port Jefferson Station, New York, United States, 11776
        • Rheumatology Associates of Long Island
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas- Houston Medical School
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Alabama at Birmingham

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Registration Dates

First Submitted

August 3, 2000

First Submitted That Met QC Criteria

August 3, 2000

First Posted (Estimate)

August 4, 2000

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/15327
  • UAB-SELENA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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