Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000419
Status:
TERMINATED
Last Update Posted:
2013-05-03
First Post:
1999-11-03
Brief Title:
Safety of Estrogens in Lupus Hormone Replacement Therapy
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Safety of Estrogens in Lupus Erythematosus - National Assessment SELENA Hormone Replacement Therapy
Status:
TERMINATED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 4000 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
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 4000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01AR042540 | NIH | None | httpsreporternihgovquickSearchU01AR042540 |