NCT00000419 is a Phase 3 clinical trial of Premarin and Provera in Systemic Lupus Erythematosus, sponsored by NYU Langone Health.

Who is sponsoring NCT00000419?

NCT00000419 is sponsored by NYU Langone Health.

What drugs are being tested in NCT00000419?

Interventions in NCT00000419: Premarin and Provera.

What condition does NCT00000419 study?

NCT00000419 studies Systemic Lupus Erythematosus.

Is NCT00000419 still recruiting?

NCT00000419 is currently terminated. Last updated 1 May 2013.

Last reviewed 2013-05-01 · How we verify

NCT00000419

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Hormone Replacement Therapy

Terminated Phase 3 Last updated 1 May 2013

What this trial tests

Phase 3 trial testing Premarin and Provera in Systemic Lupus Erythematosus in 350 participants. Terminated before completion.

Timeline

1 April 1996

1 August 2002

Quick facts

Lead sponsor	NYU Langone Health
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	treatment
Enrollment	350
Start date	1 April 1996
Estimated completion	1 August 2002
Sites	16 locations across United States

Drugs / interventions tested

Premarin and Provera — full drug profile →

Conditions studied

Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 18 to 85, female only, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Clinical trials of potential cognitive-enhancing drugs in schizophrenia: what have we learned so far?
Keefe RS, Buchanan RW, Marder SR, Schooler NR, et al · · 2013 · cited 93× · PMID 22114098 · DOI 10.1093/schbul/sbr153
Linking ClinicalTrials.gov and PubMed to track results of interventional human clinical trials.
Huser V, Cimino JJ. · · 2013 · cited 72× · PMID 23874614 · DOI 10.1371/journal.pone.0068409
MeSHing molecular sequences and clinical trials: a feasibility study.
Chen ES, Sarkar IN. · · 2010 · cited 4× · PMID 19850150 · DOI 10.1016/j.jbi.2009.10.003

Verify or expand the search:

Other recruiting trials for Systemic Lupus Erythematosus

Currently open trials in the same condition.

NCT06984341 — A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in P · Phase 1 · recruiting
NCT07526350 — MTS109 in Patients With Refractory Autoimmune Diseases · EARLY_PHASE1 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
NCT07371468 — A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) · Phase 1 · recruiting

Other NYU Langone Health trials

Trials by the same sponsor.

NCT07214519 — Permanent Supportive Housing Overdose Prevention-2 Study · NA · not yet recruiting
NCT05558267 — Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease · NA · not yet recruiting
NCT06637852 — Sexual and Urinary Function Improvement for Cancer Survivors · NA · not yet recruiting
NCT06236087 — Overdose Prevention Centers and Behavioral Health · not yet recruiting
NCT06462027 — Packed Red Blood Cell Transfusion During Cardiac Arrest · Phase 1 · suspended

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00000419 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
Last refreshed: 1 May 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00000419.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing