MedTrace Logo

Efficacy of Faslodex in Treatment of SLE Clinical, Serologic, and Molecular Studies

NCT00417430 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2009-09-22

No results posted yet for this study

Summary

SLE(Systemic Lupus Erythematosus) is an autoimmune disese that primarily occurs in women(9:1 compared to men). The disease is activated by genetic and environmental factors, yet the female gender is the strongest risk factor. The sex hormone estrogen has been proven in the past to be an enhancer of the immune response. Estrogen serves as a ligand for two specific receptor proteins. Lab studies that we have already done have shown estrogen significantly increases these two ligands in the T cells from SLE females, but not in T cells from normal women. These estrogen-dependent increases are blocked by the estrogen receptor antagonist ICI 182,780. The objective of this research is to investigate if ICI 182,780 alters disease progression and/or activity in females with SLE and may provide a new treatment for women with SLE. This is based on previous work we have done.

Conditions

Interventions

DRUG

ICI 182,780 (Faslodex)

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • The Center for Rheumatic Disease, Allergy, & Immunology

    lead OTHER

Principal Investigators

  • Nabih Abdou, MD, PhD · Center for Rheumatic Disease

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00417430 on ClinicalTrials.gov