Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006133
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-08-03
Brief Title:
Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-12
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:
OBJECTIVES I Determine the effect of oral contraceptives containing low-dose synthetic estrogens and progestins on disease activity in premenopausal women with inactive stable or moderate systemic lupus erythematosus SLE
II Determine the effect of hormone replacement therapy with conjugated estrogens and progestins on disease activity in postmenopausal women with inactive stable or moderate SLE
II Determine the effect of hormone replacement therapy with conjugated estrogens and progestins on disease activity in postmenopausal women with inactive stable or moderate SLE
Detailed Description:
PROTOCOL OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to agemenopausal status 35 and underpremenopausal vs 50 and overpostmenopausal Both strata are randomized to one of two treatment arms
Stratum 1 PremenopausalOral contraceptives Patients receive either oral ethinyl estradiol and norethindrone or placebo daily for 28 days beginning on the Sunday following the first day of the menstrual cycle
Stratum 2 PostmenopausalHormone replacement therapy Patients receive either oral estradiol and medroxyprogesterone or placebo on days 1-12 monthly
Treatment continues in both arms of both strata for a total of 13 courses in the absence of a severe disease flare-up or other complication that would preclude further study participation
All patients are followed at 1 year
Stratum 1 PremenopausalOral contraceptives Patients receive either oral ethinyl estradiol and norethindrone or placebo daily for 28 days beginning on the Sunday following the first day of the menstrual cycle
Stratum 2 PostmenopausalHormone replacement therapy Patients receive either oral estradiol and medroxyprogesterone or placebo on days 1-12 monthly
Treatment continues in both arms of both strata for a total of 13 courses in the absence of a severe disease flare-up or other complication that would preclude further study participation
All patients are followed at 1 year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UAB-SELENA | None | None | None |