AzTrials
AzTrials

Systemic Lupus ErythematosusPhase 3NCT00000419

Safety of Estrogens in Lupus: Hormone Replacement Therapy

A Phase 3 study testing Premarin and Provera in people with Systemic Lupus Erythematosus, run by NYU Langone Health at 16 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years, women only
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Premarin and Provera
How many people
350 participants
Where
16 sitesUnited States
Study dates
Apr 1996to Aug 2002
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 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

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 15Show 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 (HRT or OCP) for >1 month at any time after SLE diagnosis
  • FSH <40
  • Premenopausal myocardial infarction

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

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

    Ann Arbor, Michigan, 48109-0358

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21205

  • UAB Medical Center

    Birmingham, Alabama, 35294

  • 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

    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, Ambulatory Care Center

    Richmond, Virginia, 23219

  • Louisiana School of Medicine

    Shreveport, Louisiana, 71130-3932

  • Albert Einstein College of Medicine, Jacoby 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): Hormone Replacement Therapy

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.

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 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

Being tested
Premarin and Provera
Keywords
SLE, SELENA, Estrogen Replacement Therapy (ERT), Postmenopause, Osteoporosis, Estrogens, Steroids, Progestin, Placebo
Medical subject headings
Lupus Erythematosus, Systemic, Osteoporosis

What participants receive

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

  • Premarin and ProveraDrug

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 startApr 1996
  3. Study completionAug 2002

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
NCT00000419
Sponsor's protocol ID
U01 AR42540 NIAMS-028A
Other IDs
U01AR042540
Status last verified
May 2013
First submitted
3 Nov 1999
Last updated
3 May 2013
Results posted
No

Publications

  • 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. 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

  • 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

  • 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, 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, 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.

    PubMed 15968009

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Premarin and Provera in people with Systemic Lupus Erythematosus, run by NYU Langone Health at 16 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 4 inclusion and 15 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: stopped early, 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 16 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 was stopped early. Results are not available in the source record.

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 NCT00000419, which also lists 7 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in