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Safety of Estrogens in Lupus: Birth Control Pills

NCT00000420 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2013-05-03

No results posted yet for this study

Summary

Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether women with systemic lupus erythematosus (SLE or lupus) can safely use estrogen. We will determine this by looking at the effects of oral contraceptives (birth control pills, also known as "the pill") on disease activity and severity in women with SLE. The results of the study will show whether it is safe for women with SLE to use the pill.

Conditions

Interventions

DRUG

Ortho-Novum 777

Sponsors & Collaborators

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

    collaborator NIH

  • Office of Research on Women's Health (ORWH)

    collaborator NIH

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Jill P. Buyon, MD · Hospital for Joint Diseases

  • Michelle Petri, MD · Johns Hopkins University Hospital, Dept. of Rheumatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-06-30
Completion
2003-08-31

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 NCT00000420 on ClinicalTrials.gov