Systemic Lupus ErythematosusNCT00006133
Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus
A study testing estradiol, ethinyl estradiol and medroxyprogesterone in people with Systemic Lupus Erythematosus, run by National Center for Research Resources (NCRR) at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- estradiol, ethinyl estradiol and medroxyprogesterone
- How many people
- 970 participants
- Where
- 17 sitesUnited States
- Study dates
- Jun 2000to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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)
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of Michigan Health Systems
Ann Arbor, Michigan, 48109
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
University of North Carolina
Chapel Hill, North Carolina, 27599
Pritzker School of Medicine
Chicago, Illinois, 60637
University of Texas- Houston Medical School
Houston, Texas, 77030
University of California Los Angeles
Los Angeles, California, 90095-6951
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Hospital for Joint Diseases
New York, New York, 10003
Saint Luke's-Roosevelt Hospital Center
New York, New York, 10019
Hospital for Special Surgery
New York, New York, 10021
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Rheumatology Associates of Long Island
Port Jefferson Station, New York, 11776
University of California-San Francisco
San Francisco, California, 94143
Louisiana State University School of Medicine
Shreveport, Louisiana, 71130-3932
Montefiore Medical Center
The Bronx, New York, 10467-2490
About this study
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.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- estradiol, ethinyl estradiol, medroxyprogesterone, norethindrone
- Keywords
- arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthritis, Connective Tissue Diseases, Immune System Diseases, Communicable Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estradiolDrug
ethinyl estradiolDrug
medroxyprogesteroneDrug
norethindroneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2000 (estimated)
- Study startJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 970 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Alabama at Birmingham
- Investigators
- Graciela S. Alarcon, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006133
- Sponsor's protocol ID
- 199/15327
- Other IDs
- UAB-SELENA
- Status last verified
- Dec 2003
- First submitted
- 3 Aug 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00006133
- Acronym / sponsor ID
- 199/15327
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 970 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- University of Alabama at Birmingham
- Study start
- Jun 2000
- First posted
- 4 Aug 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estradiol | Drug | – |
| ethinyl estradiol | Drug | – |
| medroxyprogesterone | Drug | – |
| norethindrone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graciela S. Alarcon study chair
University of Alabama at Birmingham
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing estradiol, ethinyl estradiol and medroxyprogesterone in people with Systemic Lupus Erythematosus, run by National Center for Research Resources (NCRR) at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.