NCT00006133

Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 970 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: Female
• Age: 0 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age/menopausal status (35 and under/premenopausal vs 50 and over/postmenopausal). Both strata are randomized to one of two treatment arms. Stratum 1 (Premenopausal/Oral 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 (Postmenopausal/Hormone 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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	estradiol
DRUG	ethinyl estradiol
DRUG	medroxyprogesterone
DRUG	norethindrone

Timeline

• Start date: 2000-06-01
• First posted: 2000-08-04
• Last updated: 2005-06-24

Locations

17 sites across 1 country: United States