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:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT04453332
Eligibility Criteria:
Inclusion Criteria:
* Six months or more of amenorrhea and FSH levels\> or = at 35 mIU / ml;
* Menopause for a maximum of three years;
* Mammography and cytology of recent cervix (from the last 12 months);
* Signature of the Informed Consent Form.
Exclusion Criteria:
* Menopause age below 40 years;
* Use of hormonal therapy in the three months preceding the study;
* Uncontrolled diabetes mellitus;
* Endometrial thickening (endometrial thickness greater than 0.5 cm);
* Neoplasm of breast, colon or endometrium;
* History of thromboembolism or established cardiovascular disease;
* Previous hysterectomy;
* Active smoking;
* Use of medication to treat osteoporosis in the last 12 months: bisphosphonates, denosumab, teriparatide, SERMs (selective estrogen receptor agonist).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
58 Years
Study:
NCT04453332
Study Brief:
Protocol Section:
NCT04453332