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| Brief Title † | Safety of Estrogens in Lupus: Hormone Replacement Therapy | ||||||||
| Official Title † | Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Hormone Replacement Therapy | ||||||||
| Brief Summary | Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether postmenopausal women with systemic lupus erythematosus (SLE, or lupus) can safely use the hormone estrogen. In this part of the study, we will look at the effects of estrogen replacement therapy on the activity and severity of disease in women with SLE. |
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| 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 hormone replacement therapy (HRT) to women with SLE because of the widely held view that such treatment 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 HRT. We will examine, in a multicenter, randomized, double-blind, placebo-controlled trial, the effect of hormonal replacement with conjugated estrogens on disease activity in postmenopausal women with SLE. We will recruit patients from clinics and private practices that include over 4,000 women with SLE, most belonging to minority groups. We will give patients hormones for 1 year. NOTE: This trial has been terminated as of August 2002 upon recommendation of the Data Safety Monitoring Board (DSMB), based on the findings of the WHI Trial. Study subjects have discontinued study drug but will continue followup visits to study doctors through May 2003 |
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| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Systemic Lupus Erythematosus | ||||||||
| Intervention † | Drug: Premarin and Provera | ||||||||
| MEDLINE PMIDs | 15968009, 10568907, 10568898, 11123033, 9458619, 9259444 | ||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Terminated | ||||||||
| Enrollment † | 350 | ||||||||
| Start Date † | April 1996 | ||||||||
| Completion Date | August 2002 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
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| NCT ID † | NCT00000419 | ||||||||
| Organization ID | U01 AR42540 NIAMS-028A | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||||||
| Collaborators †† | Office of Research on Women's Health (ORWH) | ||||||||
| Investigators † |
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| Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||||||
| Verification Date | October 2002 | ||||||||
| First Received Date † | November 3, 1999 | ||||||||
| Last Updated Date | January 3, 2007 | ||||||||
