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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00000419
Date of registration:	03/11/1999
Prospective Registration:	No
Primary sponsor:	New York University School of Medicine
Public title:	Safety of Estrogens in Lupus: Hormone Replacement Therapy
Scientific title:	Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Hormone Replacement Therapy
Date of first enrolment:	April 1996
Target sample size:	350
Recruitment status:	Terminated
URL:	http://clinicaltrials.gov/show/NCT00000419
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Phase:	Phase 3

Countries of recruitment
United States

Contacts

Name:	Michelle Petri, M.D.
Address:
Telephone:
Email:
Affiliation:	Johns Hopkins Hospital, Department of Rheumatology

Name:	Jill Buyon, M.D.
Address:
Telephone:
Email:
Affiliation:	Hospital for Joint Diseases, Department of Rheumatology

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 85 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Premarin and Provera

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

U01 AR42540 NIAMS-028A

U01AR042540

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Office of Research on Women's Health (ORWH)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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