NCT00000420

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 1997

Longer than P75 for phase_3

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1997

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

May 3, 2013

Status Verified

May 1, 2013

First QC Date

November 3, 1999

Last Update Submit

May 1, 2013

Conditions

Systemic Lupus Erythematosus

Keywords

SLESELENAOral contraceptivesThe pillBirth controlCondomDiaphragmEstrogenLupusPlacebo

Interventions

Ortho-Novum 777DRUG

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

UCLA Medical Center, Dept. of Rheumatology

Los Angeles, California, 90024, United States

Location

University of Chicago Pritzker School of Medicine

Chicago, Illinois, 60637, United States

Location

Louisiana School of Medicine, Dept. of Medicine/Immunology

Shreveport, Louisiana, 71130-3932, United States

Location

Johns Hopkins Hospital, Dept. of Rheumatology

Baltimore, Maryland, 21205, United States

Location

Univ. of Michigan Med. Ctr., Rheumatology Division

Ann Arbor, Michigan, 48109-0358, United States

Location

Hospital for Joint Diseases

New York, New York, 10003, United States

Location

Hospital for Special Surgery, Dept. of Rheumatology

New York, New York, 10021, United States

Location

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

The Bronx, New York, 10461, United States

Location

UNC Medical Center, Dept. of Rheumatology

Chapel Hill, North Carolina, 27599-7280, United States

Location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

Univ. of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Univ. of Pittsburgh, Dept. of Rheumatology

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Health Sciences Center

Houston, Texas, 77030, United States

Location

Medical College of Virginia

Richmond, Virginia, 23219, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (8)

  • 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.

    PMID: 11123033BACKGROUND

  • 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.

    PMID: 10568907BACKGROUND

  • 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.

    PMID: 10568898BACKGROUND

  • 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.

    PMID: 9259444BACKGROUND

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

    PMID: 8952745BACKGROUND

  • 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.

    BACKGROUND

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

    PMID: 9458619BACKGROUND

  • 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.

    PMID: 16354891RESULT

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jill P. Buyon, MD

    Hospital for Joint Diseases

    PRINCIPAL INVESTIGATOR

  • Michelle Petri, MD

    Johns Hopkins University Hospital, Dept. of Rheumatology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

June 1, 1997

Study Completion

August 1, 2003

Last Updated

May 3, 2013

Record last verified: 2013-05

Locations

US(15)