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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006133
Recruitment Status : Completed
First Posted : August 4, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: estradiol Drug: ethinyl estradiol Drug: medroxyprogesterone Drug: norethindrone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 970 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : June 2000

Resource links provided by the National Library of Medicine






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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006133


Locations
Show Show 17 study locations
Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Alabama at Birmingham
Investigators
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Study Chair: Graciela S. Alarcon University of Alabama at Birmingham
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ClinicalTrials.gov Identifier: NCT00006133    
Other Study ID Numbers: 199/15327
UAB-SELENA
First Posted: August 4, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003
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:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Medroxyprogesterone Acetate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Medroxyprogesterone
Norethindrone
Norethindrone Acetate
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents