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Systemic Lupus ErythematosusPhase 3NCT00000420

Safety of Estrogens in Lupus: Birth Control Pills

A Phase 3 study testing Ortho-Novum 777 in people with Systemic Lupus Erythematosus, run by NYU Langone Health at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether women with systemic lupus erythematosus (SLE or lupus) can safely use estrogen. Read more about this study

Who is it for?
Ages 18 to 39 years, women only
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Ortho-Novum 777
How many people
350 participants
Where
15 sitesUnited States
Study dates
Jun 1997to Aug 2003
Phase
Phase 3
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 18 to 39 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female
  • Unequivocal diagnosis of SLE
  • Inactive disease or be stable on 0.5 mg/kg/day or less of predisone
  • Must be between 18 and 39 years old if non-smoker
  • Must be between 18 and 35 years old if smoker

Who cannot join

  • Blood pressure >145/95 on three occasions
  • Deep vein, arterial thrombosis or pulmonary embolus
  • GPL >40; MPL >40; APL >50; dRVVT >37 sec
  • APL antibody syndrome ever
  • Gynecologic or breast cancer
  • Hepatic dysfunction or liver tumors
Show all 16Show fewer
  • Diabetes mellitus (NOT due to steroids) with vascular disease
  • Congenital hyperlipidemia
  • Complicated migraine
  • Severe disease activity (SLEDAI >12)
  • Increase in SLEDAI >2 points in 3 months
  • Unexplained vaginal bleeding
  • Use of estrogen (OCP) for >1 month at any time after SLE diagnosis
  • Present pregnancy
  • Angina or MI due to APS
  • Age >35 yrs. for smokers; >39 yrs. for nonsmokers

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Univ. of Michigan Med. Ctr., Rheumatology Division

    Ann Arbor, Michigan, 48109-0358

  • Johns Hopkins Hospital, Dept. of Rheumatology

    Baltimore, Maryland, 21205

  • UNC Medical Center, Dept. of Rheumatology

    Chapel Hill, North Carolina, 27599-7280

  • University of Chicago Pritzker School of Medicine

    Chicago, Illinois, 60637

  • University of Texas Health Sciences Center

    Houston, Texas, 77030

  • UCLA Medical Center, Dept. of Rheumatology

    Los Angeles, California, 90024

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Hospital for Joint Diseases

    New York, New York, 10003

  • Hospital for Special Surgery, Dept. of Rheumatology

    New York, New York, 10021

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104

  • Univ. of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104

  • Univ. of Pittsburgh, Dept. of Rheumatology

    Pittsburgh, Pennsylvania, 15213

  • Medical College of Virginia

    Richmond, Virginia, 23219

  • Louisiana School of Medicine, Dept. of Medicine/Immunology

    Shreveport, Louisiana, 71130-3932

  • Albert Einstein College of Medicine, Jacobi Hospital, Dept. of Rheumatology

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Oral Contraceptives

Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether women with systemic lupus erythematosus (SLE or lupus) can safely use estrogen. We will determine this by looking at the effects of oral contraceptives (birth control pills, also known as "the pill") on disease activity and severity in women with SLE. The results of the study will show whether it is safe for women with SLE to use the pill.

Read the detailed description

This study tests the effect of exogenous female hormones on disease activity and severity in women with systemic lupus erythematosus (SLE). Physicians generally do not prescribe oral contraceptives (OCs) to women with lupus because of the widely held view that these drugs can activate SLE. This practice is based on the greater incidence of SLE in women than in men, biologic abnormalities of estrogen metabolism, murine models of lupus, several anecdotes of patients having disease flares while receiving exogenous hormones, and a single retrospective study in patients with preexisting renal disease.

By contrast, recent retrospective studies suggest that the rate of flare is not significantly increased in patients taking OCs. The preexisting data is insufficient to warrant the dismissal of a potentially important birth control option in a disease that predominantly affects women in their reproductive years and whose fertility is not altered by the disease. Moreover, the use of OCs to preserve fertility in patients taking cyclophosphamide and the use of estrogens to prevent coronary artery disease and postmenopausal and steroid-induced osteoporosis are timely considerations.

We will attempt to define, in a multicenter, randomized, double-blind, placebo-controlled trial, the effect of OCs containing low-dose synthetic estrogens and progestins on disease activity in women with SLE. Because the research hypothesis is that OCs do not increase the risk of flares, we have designed the study to be able to detect minimal increases in the rate of flares in patients taking OCs.

We will enroll patients with inactive, stable, or moderate disease requiring less than 0.5 mg prednisone per kg of bodyweight per day over a 2-year period and randomize them to receive birth control pills or placebo pills for 12 months. During that time, the patient must use condoms or a diaphragm as birth control. We will recruit patients from clinics and private practices that include over 4,000 women with SLE, most belonging to minority groups.

Being tested
Ortho-Novum 777
Keywords
SLE, SELENA, Oral contraceptives, The pill, Birth control, Condom, Diaphragm, Estrogen, Lupus, Placebo
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ortho-Novum 777Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 1999 (estimated)
  2. Study startJun 1997
  3. Study completionAug 2003

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Enrolment
350 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000420
Sponsor's protocol ID
U01 AR42540 NIAMS-028B
Other IDs
U01AR042540
Status last verified
May 2013
First submitted
3 Nov 1999
Last updated
3 May 2013
Results posted
No

Publications

  • Buyon JP. Clinical trials in systemic lupus erythematosus. Curr Rheumatol Rep. 2000 Feb;2(1):11-12. doi: 10.1007/s11926-996-0062-y. No abstract available.

    PubMed 11123033

  • Petri M, Buyon J, Kim M. Classification and definition of major flares in SLE clinical trials. Lupus. 1999;8(8):685-91. doi: 10.1191/096120399680411281.

    PubMed 10568907

  • Kim MY, Buyon JP, Petri M, Skovron ML, Shore RE. Equivalence trials in SLE research: issues to consider. Lupus. 1999;8(8):620-6. doi: 10.1191/096120399680411308.

    PubMed 10568898

  • Buyon JP, Dooley MA, Meyer WR, Petri M, Licciardi F. Recommendations for exogenous estrogen to prevent glucocorticoid-induced osteoporosis in premenopausal women with oligo- or amenorrhea: comment on the American College of Rheumatology recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Rheum. 1997 Aug;40(8):1548-9. doi: 10.1002/art.1780400831. No abstract available.

    PubMed 9259444

  • Buyon JP. Oral contraceptives in women with systemic lupus erythematosus. Ann Med Interne (Paris). 1996;147(4):259-64.

    PubMed 8952745

  • Buyon JP, Wallace DJ. The endocrine system, use of exogenous estrogens, and the urogenital tract. In Dubois' Lupus Erythematosus, 6th edition. Wallace DJ, Hahn BH, eds. Philadelphia: Lippincott Williams & Wilkins, 2002; pp. 821-841.

  • Buyon JP. Hormone replacement therapy in postmenopausal women with systemic lupus erythematosus. J Am Med Womens Assoc (1972). 1998 Winter;53(1):13-7.

    PubMed 9458619

  • Petri M, Kim MY, Kalunian KC, Grossman J, Hahn BH, Sammaritano LR, Lockshin M, Merrill JT, Belmont HM, Askanase AD, McCune WJ, Hearth-Holmes M, Dooley MA, Von Feldt J, Friedman A, Tan M, Davis J, Cronin M, Diamond B, Mackay M, Sigler L, Fillius M, Rupel A, Licciardi F, Buyon JP; OC-SELENA Trial. Combined oral contraceptives in women with systemic lupus erythematosus. N Engl J Med. 2005 Dec 15;353(24):2550-8. doi: 10.1056/NEJMoa051135.

    PubMed 16354891

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ortho-Novum 777 in people with Systemic Lupus Erythematosus, run by NYU Langone Health at 15 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?

The sponsor lists 5 inclusion and 16 exclusion criteria. 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 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

On the ClinicalTrials.gov record for NCT00000420, which also lists 8 linked publications.

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 3 May 2013.

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