Status:
COMPLETED
Effect of Hormone Replacement Therapy on Lupus Activity
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Conditions:
Systemic Lupus Erythematosus
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief Summary
Hypothesis, HRT does not increase the risk of lupus activity exacerbation, it is effective for the relief of menopausal symptoms and improves bone mineral density. Double-blind, randomized, placebo c...
Detailed Description
Background Systemic Lupus Erythematosus (SLE) is an autoimmune disease of unknown cause. Risk factors proposed as important in the pathogenesis of SLE include genetic, environmental, and hormonal fact...
Eligibility Criteria
Inclusion
- Eligible women will be those having any two of the following criteria
- Amenorrhea of 6 months or more.
- Serum follicle-stimulating hormone level of 30 IU/L or more.
- Menopausal symptoms.
- Age 48 years or older.
Exclusion
- Women older than 65 years.
- Severe lupus activity at baseline (SLEDAI score, more than 30).
- Use of estrogens within 3 months of the screening visit.
- Serum creatinine of 2.0 mg/dL or more.
- Hypertriglyceridemia 500 mg/dL or more.
- Metabolic bone diseases.
- Liver disease.
- Untreated hyperthyroidism.
- Recent thrombosis.
- Malignancy.
- Endometrial hyperplasia.
- Undiagnosed uterine bleeding or cervical dysplasia
Key Trial Info
Start Date :
November 1 1997
Trial Type :
INTERVENTIONAL
End Date :
December 1 2001
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00392093
Start Date
November 1 1997
End Date
December 1 2001
Last Update
October 25 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
I
México, Mexico