Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT00392093
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00392093
Study Brief:
Protocol Section:
NCT00392093