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Trial record 2 of 55 for:    selena

Safety of Estrogens in Lupus: Birth Control Pills

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000420
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : May 3, 2013
Sponsor:
Collaborators:
Information provided by:

November 3, 1999
November 4, 1999
May 3, 2013
June 1997
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Complete list of historical versions of study NCT00000420 on ClinicalTrials.gov Archive Site
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Safety of Estrogens in Lupus: Birth Control Pills
Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Oral Contraceptives
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Systemic Lupus Erythematosus
Drug: Ortho-Novum 777
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
August 2003
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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
Sexes Eligible for Study: Female
18 Years to 39 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00000420
U01 AR42540 NIAMS-028B
U01AR042540 ( U.S. NIH Grant/Contract )
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New York University School of Medicine
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Office of Research on Women's Health (ORWH)
Principal Investigator: Jill P. Buyon, MD Hospital for Joint Diseases
Study Director: Michelle Petri, MD Johns Hopkins University Hospital, Dept. of Rheumatology
New York University School of Medicine
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP