Trial record 10 of 85 for:    Lupus AND (woman OR women OR female)

Safety of Estrogens in Lupus: Birth Control Pills

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00000420
First received: November 3, 1999
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: Ortho-Novum 777
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Oral Contraceptives

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Estimated Enrollment: 350
Study Start Date: June 1997
Estimated Study Completion Date: August 2003
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 oral contraceptives (OCs) to women with lupus because of the widely held view that these drugs 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 OCs. The preexisting data is insufficient to warrant the dismissal of a potentially important birth control option in a disease that predominantly affects women in their reproductive years and whose fertility is not altered by the disease. Moreover, the use of OCs to preserve fertility in patients taking cyclophosphamide and the use of estrogens to prevent coronary artery disease and postmenopausal and steroid-induced osteoporosis are timely considerations.

We will attempt to define, in a multicenter, randomized, double-blind, placebo-controlled trial, the effect of OCs containing low-dose synthetic estrogens and progestins on disease activity in women with SLE. Because the research hypothesis is that OCs do not increase the risk of flares, we have designed the study to be able to detect minimal increases in the rate of flares in patients taking OCs.

We will enroll patients with inactive, stable, or moderate disease requiring less than 0.5 mg prednisone per kg of bodyweight per day over a 2-year period and randomize them to receive birth control pills or placebo pills for 12 months. During that time, the patient must use condoms or a diaphragm as birth control. We will recruit patients from clinics and private practices that include over 4,000 women with SLE, most belonging to minority groups.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • Unequivocal diagnosis of SLE
  • Inactive disease or be stable on 0.5 mg/kg/day or less of predisone
  • Must be between 18 and 39 years old if non-smoker
  • Must be between 18 and 35 years old if smoker

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 (OCP) for >1 month at any time after SLE diagnosis
  • Present pregnancy
  • Angina or MI due to APS
  • Age >35 yrs. for smokers; >39 yrs. for nonsmokers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000420

Locations
United States, California
UCLA Medical Center, Dept. of Rheumatology
Los Angeles, California, United States, 90024
United States, Illinois
University of Chicago Pritzker School of Medicine
Chicago, Illinois, United States, 60637
United States, Louisiana
Louisiana School of Medicine, Dept. of Medicine/Immunology
Shreveport, Louisiana, United States, 71130-3932
United States, Maryland
Johns Hopkins Hospital, Dept. of Rheumatology
Baltimore, Maryland, United States, 21205
United States, Michigan
Univ. of Michigan Med. Ctr., Rheumatology Division
Ann Arbor, Michigan, United States, 48109-0358
United States, New York
Albert Einstein College of Medicine, Jacobi Hospital, Dept. of Rheumatology
Bronx, New York, United States, 10461
Hospital for Special Surgery, Dept. of Rheumatology
New York, New York, United States, 10021
Hospital for Joint Diseases
New York, New York, United States, 10003
United States, North Carolina
UNC Medical Center, Dept. of Rheumatology
Chapel Hill, North Carolina, United States, 27599-7280
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Univ. of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Univ. of Pittsburgh, Dept. of Rheumatology
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Health Sciences Center
Houston, Texas, United States, 77030
United States, Virginia
Medical College of Virginia
Richmond, Virginia, United States, 23219
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Jill P. Buyon, MD Hospital for Joint Diseases
Study Director: Michelle Petri, MD Johns Hopkins University Hospital, Dept. of Rheumatology
  More Information

Publications:
Buyon JP. Oral contraceptives in women with SLE. Annales de Medicine Interne 1996; 147:259-264.
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.

ClinicalTrials.gov Identifier: NCT00000420     History of Changes
Other Study ID Numbers: U01 AR42540 NIAMS-028B, U01AR042540
Study First Received: November 3, 1999
Last Updated: May 1, 2013
Health Authority: United States: Federal Government

Keywords provided by New York University School of Medicine:
SLE
SELENA
Oral contraceptives
The pill
Birth control
Condom
Diaphragm
Estrogen
Lupus
Placebo

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Contraceptive Agents, Female
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Contraceptive Agents
Norinyl
Ethynylestradiol mixture with norethindrone
Contraceptives, Oral
Contraceptives, Oral, Combined
Estrogens
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Hormonal
Contraceptives, Oral, Sequential
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on August 26, 2014