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Safety of Estrogens in Lupus: Hormone Replacement Therapy

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ClinicalTrials.gov Identifier: NCT00000419
Recruitment Status : Terminated
First Posted : November 4, 1999
Last Update Posted : May 3, 2013
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Office of Research on Women's Health (ORWH)
Information provided by:
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE November 3, 1999
First Posted Date  ICMJE November 4, 1999
Last Update Posted Date May 3, 2013
Study Start Date  ICMJE April 1996
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Estrogens in Lupus: Hormone Replacement Therapy
Official Title  ICMJE Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Hormone Replacement Therapy
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.
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 hormone replacement therapy (HRT) to women with SLE because of the widely held view that such treatment 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 HRT.

We will examine, in a multicenter, randomized, double-blind, placebo-controlled trial, the effect of hormonal replacement with conjugated estrogens on disease activity in postmenopausal women with SLE. We will recruit patients from clinics and private practices that include over 4,000 women with SLE, most belonging to minority groups.

We will give patients hormones for 1 year.

NOTE: This trial has been terminated as of August 2002 upon recommendation of the Data Safety Monitoring Board (DSMB), based on the findings of the WHI Trial. Study subjects have discontinued study drug but will continue followup visits to study doctors through May 2003

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE Drug: Premarin and Provera
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
350
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000419
Other Study ID Numbers  ICMJE U01 AR42540 NIAMS-028A
U01AR042540 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Office of Research on Women's Health (ORWH)
Investigators  ICMJE
Principal Investigator: Jill Buyon, M.D. Hospital for Joint Diseases, Department of Rheumatology
Study Director: Michelle Petri, M.D. Johns Hopkins Hospital, Department of Rheumatology
PRS Account NYU Langone Health
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP