Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-31 @ 8:58 PM
Study NCT ID:
NCT00006133
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004997', 'term': 'Ethinyl Estradiol'}, {'id': 'D008525', 'term': 'Medroxyprogesterone'}, {'id': 'D009640', 'term': 'Norethindrone'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009651', 'term': 'Norpregnatrienes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D042782', 'term': 'Estrogenic Steroids, Alkylated'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D009652', 'term': 'Norpregnenes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 970}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-12', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2000-08-03', 'studyFirstSubmitQcDate': '2000-08-03', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-08-04', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['arthritis & connective tissue diseases', 'immunologic disorders and infectious disorders', 'rare disease', 'systemic lupus erythematosus'], 'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': '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).\n\nII. Determine the effect of hormone replacement therapy with conjugated estrogens and progestins on disease activity in postmenopausal women with inactive, stable, or moderate SLE.', 'detailedDescription': '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.\n\nStratum 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.\n\nStratum 2 (Postmenopausal/Hormone replacement therapy): Patients receive either oral estradiol and medroxyprogesterone or placebo on days 1-12 monthly.\n\nTreatment 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.\n\nAll patients are followed at 1 year.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'PROTOCOL ENTRY CRITERIA:\n\n--Disease Characteristics--\n\nEstablished systemic lupus erythematosus meeting American College of Rheumatology criteria\n\nInactive disease Systemic Lupus Erythematosus Activity Index (SLEDAI) score no greater than 4\n\nNo increase in score of more than 2 from baseline over the past 3 months\n\nReceiving the equivalent of 5 mg or less of prednisone per day OR Stable/active disease SLEDAI score 5-12\n\nNo increase in score of more than 2 from baseline over the past 3 months\n\nPrednisone dose up to 0.5 mg/kg/day for control of underlying disease allowed if stable dose for at least 3 weeks\n\nNo concurrent severe disease activity as defined by any of the following:\n\n* Acute renal disease (i.e., rising creatinine levels, cellular sediment, or increasing proteinuria)\n* Involvement of 3 or more organ systems requiring more than the equivalent of 0.5 mg/kg/day of prednisone\n* Necessity of immediate hospitalization for symptom control\n\nNo presence of a high titer IgG, IgM, or IgA antiphospholipid antibodies (aPL) GPL and MPL no more than 40 APL no more than 50\n\nNo features of primary antiphospholipid antibody syndrome\n\n--Prior/Concurrent Therapy--\n\nBiologic therapy: Not specified\n\nChemotherapy: Not specified\n\nEndocrine therapy: See Disease Characteristics\n\nRadiotherapy: Not specified\n\nSurgery: Prior hysterectomy allowed\n\n--Patient Characteristics--\n\nAge: 35 and under for oral contraceptive stratum (premenopausal) 50 and over for hormone replacement therapy stratum (postmenopausal)\n\nMenopausal status:\n\n* Premenopausal for oral contraceptive stratum\n* Postmenopausal for hormone replacement therapy stratum\n* Follicle-stimulating hormone greater than 40 mIU/mL OR Amenorrhea for 6 months\n\nPerformance status: See Disease Characteristics\n\nHematopoietic: Not specified\n\nHepatic:\n\n* No hepatic dysfunction\n* No tumors of the liver\n\nRenal: See Disease Characteristics\n\nCardiovascular:\n\n* No uncontrolled high blood pressure requiring frequent change in medication\n* Concurrent hypertension controlled with stable medication allowed\n* No history of spontaneous superficial or deep venous thrombosis or arterial thrombosis\n* No prior myocardial infarction\n* 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\n* 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\n\nPulmonary: No history of pulmonary embolus\n\nOther:\n\n* Not pregnant\n* Oral contraceptive stratum: Negative pregnancy test Fertile patients must use effective barrier contraception\n* No prior gynecologic malignancy or breast malignancy\n* No undiagnosed vaginal bleeding\n* No diabetes (present prior to use of glucocorticoids) requiring oral hypoglycemic medications or insulin\n* No congenital hyperlipidemia\n* No complicated migraines (i.e., associated with neurological sequelae)'}, 'identificationModule': {'nctId': 'NCT00006133', 'briefTitle': 'Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus', 'organization': {'class': 'NIH', 'fullName': 'National Center for Research Resources (NCRR)'}, 'orgStudyIdInfo': {'id': '199/15327'}, 'secondaryIdInfos': [{'id': 'UAB-SELENA'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'estradiol', 'type': 'DRUG'}, {'name': 'ethinyl estradiol', 'type': 'DRUG'}, {'name': 'medroxyprogesterone', 'type': 'DRUG'}, {'name': 'norethindrone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama Comprehensive Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90095-6951', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California-San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Pritzker School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '71130-3932', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University School of Medicine', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health Systems', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Joint Diseases', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Saint Luke's-Roosevelt Hospital Center", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11776', 'city': 'Port Jefferson Station', 'state': 'New York', 'country': 'United States', 'facility': 'Rheumatology Associates of Long Island', 'geoPoint': {'lat': 40.92538, 'lon': -73.04733}}, {'zip': '10467-2490', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15260', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas- Houston Medical School', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Graciela S. Alarcon', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}, 'collaborators': [{'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}]}}}