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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Systemic Lupus Erythematosus | Drug: Ortho-Novum 777 | Phase 3 |
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 : | Interventional (Clinical Trial) |
| Enrollment : | 350 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Oral Contraceptives |
| Study Start Date : | June 1997 |
| Study Completion Date : | August 2003 |
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 39 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000420
| 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 Joint Diseases | |
| New York, New York, United States, 10003 | |
| Hospital for Special Surgery, Dept. of Rheumatology | |
| New York, New York, United States, 10021 | |
| 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 | |
| Principal Investigator: | Jill P. Buyon, MD | Hospital for Joint Diseases | |
| Study Director: | Michelle Petri, MD | Johns Hopkins University Hospital, Dept. of Rheumatology |
Other Publications:
| ClinicalTrials.gov Identifier: | NCT00000420 |
| Other Study ID Numbers: |
U01 AR42540 NIAMS-028B U01AR042540 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 4, 1999 Key Record Dates |
| Last Update Posted: | May 3, 2013 |
| Last Verified: | May 2013 |
|
SLE SELENA Oral contraceptives The pill Birth control |
Condom Diaphragm Estrogen Lupus Placebo |
|
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Norinyl Contraceptives, Oral, Combined Contraceptives, Oral |
Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptives, Oral, Hormonal Contraceptive Agents, Hormonal |