Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000420
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
1999-11-03
Brief Title:
Safety of Estrogens in Lupus Birth Control Pills
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Safety of Estrogens in Lupus Erythematosus - National Assessment SELENA Oral Contraceptives
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 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 05 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 4000 women with SLE most belonging to minority groups
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 05 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 4000 women with SLE most belonging to minority groups
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 |