Trial record 6 of 84 for:    Lupus AND (woman OR women OR female)

Effect of Hormone Replacement Therapy on Lupus Activity

This study has been completed.
Sponsor:
Information provided by:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT00392093
First received: October 23, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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 controlled clinical trial.

Objectives

  1. Determine the effect of HRT on disease activity, menopausal symptoms, bone mineral density, lipid profile, and mammographic parenchymal density in menopausal women with SLE.
  2. Determine the incidence rate of major side effects of HRT in menopausal women with SLE.

Outcome Measures

  1. Primary outcome will be global disease activity throughout the follow-up period.
  2. Incidence of lupus flares, time to the first flare, changes in SLEDAI values from baseline at each follow-up visit, maximum disease activity, lupus treatment, hospitalizations, thromboses, and deaths.

Menopausal symptoms and depression will be assessed utilizing the Greene Climacteric Scale questionnaire and the Beck Depression Inventory.

Bone mineral density of lumbar spine and hip will be performed with dual energy x-ray absorptiometry. In addition, blood and urine samples to measure biochemical markers of bone turnover.

Estradiol levels, lipid profile,coagulation tests, cervical cytology examinations, mammography.

Inclusion Criteria: (Any two of the following criteria)

  1. Amenorrhea of 6 months or more
  2. Serum FSH level of 30 IU/L or more
  3. Menopausal symptoms
  4. Age 48 years or older.

Exclusion Criteria:

  1. Women older than 65 years
  2. Severe lupus activity at baseline
  3. Use of estrogens within 3 months of the screening visit
  4. Serum creatinine of 2.0 mg/dL or more
  5. Hypertriglyceridemia 500 mg/dL or more
  6. Metabolic bone diseases
  7. Liver disease
  8. Untreated hyperthyroidism
  9. Recent thrombosis
  10. Malignancy
  11. Endometrial hyperplasia
  12. Undiagnosed uterine bleeding
  13. Cervical dysplasia.

Subject allocation Random assign, using a computer-generated randomization list to: Conjugated equine estrogens 0.625 mg/day plus 5 mg/day of medroxyprogesterone acetate p.o. for the first 10 days per-month, or biologically inert placebo.All women will receive 1200 mg of calcium carbonate and 800 IU of vitamin D, daily.

Follow-up procedure All patients will be evaluated by a rheumatologist and a reproductive health specialist at baseline,1,2,3,6,9,12,15,18,21, and 24 months.

Rheumatic evaluation:

  1. General information (baseline).
  2. Lupus activity (every visit).
  3. Medications: (every visit)

Gynecological evaluation:

Onset of symptoms since the previous visit using a standardized questionnaire. In addition, a gynecological examination will be performed.

Criteria for early termination of the study:

A patient will be discontinued from the study whenever any of the following criteria would be present:

  1. Development of severe lupus activity (SLEDAI > 30).
  2. Development of any putative complication to hormone therapy.
  3. Development of any other severe complications due neither to SLE nor hormone therapy.
  4. Need prolonged immobilization.

Statistical analysis:

Between-group comparisons of lupus activity, maximum SLEDAI, and change in SLEDAI score from baseline at each follow-up visit. Incidence-density rates of flares with relative risk and 95 percent confidence intervals.Probability of flares throughout the study using life-table analyses and log-rank test.

Climacteric symptoms as the mean value of the Green’s scale score at baseline and at each follow-up visit, between-group and intra-group. Bone mineral density as the mean value at baseline, 12 and 24 months, between and intra-group.

The proportion of patients in each group who develop secondary effects, as well as the number who quit the study during the follow-up period.

Continuous variables will be compared using Student's t-test, and categorical variables using chi-square or Fisher’s exact test. Within-group comparisons will be done using the Wilcoxon signed-rank test. P values will be two-sided. Analyses will be conducted by the intention-to-treat method.


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: Conjugated equine estrogens 0.625 mg/d + MPA 5 mg/d/10d
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect Of Hormone Replacement Therapy On Disease Activity, Menopausal Symptoms And Bone Mineral Density In Peri/Postmenopausal Women With Systemic Lupus Erythematosus.Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • Global disease activity throughout the follow-up period, estimated as the area under the SLEDAI-curve

Secondary Outcome Measures:
  • Incidence of lupus flares
  • Time to the first flare
  • Changes in SLEDAI values from baseline at each follow-up visit
  • Maximum disease activity
  • Improvement of menopause symptoms
  • Improvement in bone mineral density
  • Change in mammographic breast density
  • Changes in lipid profile

Estimated Enrollment: 108
Study Start Date: November 1997
Estimated Study Completion Date: December 2001
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligible women will be those having any two of the following criteria

  1. Amenorrhea of 6 months or more.
  2. Serum follicle-stimulating hormone level of 30 IU/L or more.
  3. Menopausal symptoms.
  4. Age 48 years or older.

Exclusion Criteria:

  1. Women older than 65 years.
  2. Severe lupus activity at baseline (SLEDAI score, more than 30).
  3. Use of estrogens within 3 months of the screening visit.
  4. Serum creatinine of 2.0 mg/dL or more.
  5. Hypertriglyceridemia 500 mg/dL or more.
  6. Metabolic bone diseases.
  7. Liver disease.
  8. Untreated hyperthyroidism.
  9. Recent thrombosis.
  10. Malignancy.
  11. Endometrial hyperplasia.
  12. Undiagnosed uterine bleeding or cervical dysplasia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392093

Locations
Mexico
I
Mexico, Mexico
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
Principal Investigator: Jorge Sanchez-Guerrero, MD, MS Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Chair: Maria C Cravioto, MD Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  More Information

No publications provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00392093     History of Changes
Other Study ID Numbers: JSG1957
Study First Received: October 23, 2006
Last Updated: October 23, 2006
Health Authority: Mexico: National Council of Science and Technology

Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Systemic lupus erythematosus
Menopause hormonal therapy
Menopausal symptoms
Bone mineral density

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Estrogens
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014