NCT00000419

Brief Summary

Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether postmenopausal women with systemic lupus erythematosus (SLE, or lupus) can safely use the hormone estrogen. In this part of the study, we will look at the effects of estrogen replacement therapy on the activity and severity of disease in women with SLE.

Trial Health

57
Monitor

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 Apr 1996

Longer than P75 for phase_3

Geographic Reach
1 country

16 active sites

Status
terminated

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

April 1, 1996

Completed
3.6 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
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

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

SLESELENAEstrogen Replacement Therapy (ERT)PostmenopauseOsteoporosisEstrogensSteroidsProgestinPlacebo

Interventions

Premarin and ProveraDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Unequivocal diagnosis of SLE
  • Inactive disease or stable on 0.5 mg/kg/day or less of prednisone
  • Chemical evidence of menopause or have stopped periods for at least 6 months

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 (HRT or OCP) for \>1 month at any time after SLE diagnosis
  • FSH \<40
  • Premenopausal myocardial infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

UAB Medical Center

Birmingham, Alabama, 35294, United States

Location

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

Shreveport, Louisiana, 71130-3932, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Univ. of Michigan Med. Ctr., Rheumatology Div.

Ann Arbor, Michigan, 48109-0358, United States

Location

Hospital for Joint Diseases

New York, New York, 10003, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Albert Einstein College of Medicine, Jacoby 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, Ambulatory Care Center

Richmond, Virginia, 23219, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (7)

  • 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. 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

  • 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

  • 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, 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, Petri MA, Kim MY, Kalunian KC, Grossman J, Hahn BH, Merrill JT, Sammaritano L, Lockshin M, Alarcon GS, Manzi S, Belmont HM, Askanase AD, Sigler L, Dooley MA, Von Feldt J, McCune WJ, Friedman A, Wachs J, Cronin M, Hearth-Holmes M, Tan M, Licciardi F. The effect of combined estrogen and progesterone hormone replacement therapy on disease activity in systemic lupus erythematosus: a randomized trial. Ann Intern Med. 2005 Jun 21;142(12 Pt 1):953-62. doi: 10.7326/0003-4819-142-12_part_1-200506210-00004.

    PMID: 15968009RESULT

MeSH Terms

Conditions

Lupus Erythematosus, SystemicOsteoporosis

Interventions

Estrogens, Conjugated (USP)Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Estradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsMedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Jill Buyon, M.D.

    Hospital for Joint Diseases, Department of Rheumatology

    PRINCIPAL INVESTIGATOR

  • Michelle Petri, M.D.

    Johns Hopkins Hospital, Department 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

April 1, 1996

Study Completion

August 1, 2002

Last Updated

May 3, 2013

Record last verified: 2013-05

Locations

US(16)