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Safety of Estrogens in Lupus: Birth Control Pills

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ClinicalTrials.gov Identifier: NCT00000420
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : May 3, 2013
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Office of Research on Women's Health (ORWH)
Information provided by:
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE November 3, 1999
First Posted Date  ICMJE November 4, 1999
Last Update Posted Date May 3, 2013
Study Start Date  ICMJE June 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Estrogens in Lupus: Birth Control Pills
Official Title  ICMJE Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Oral Contraceptives
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE Drug: Ortho-Novum 777
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
350
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000420
Other Study ID Numbers  ICMJE U01 AR42540 NIAMS-028B
U01AR042540 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Office of Research on Women's Health (ORWH)
Investigators  ICMJE
Principal Investigator: Jill P. Buyon, MD Hospital for Joint Diseases
Study Director: Michelle Petri, MD Johns Hopkins University Hospital, Dept. of Rheumatology
PRS Account NYU Langone Health
Verification Date May 2013

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