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:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT06136208
Eligibility Criteria:
Inclusion Criteria:
* Signed Informed Consent Form
* Woman aged ≥ 41 and ≤ 59 years
* Weight ≥ 50 kg and ≤ 98 kg
* BMI ≥ 18.5 and ≤ 34.9 kg/m²
* Hysterectomy (with or without oophorectomy)
* Serum total estradiol concentration ≤ 50 pg/mL and serum FSH concentration ≥ 25 mIU/mL, both determined by immunoassays
* Presence of menopause-associated symptoms
* Absence of signs and symptoms and propedeutics suggestive of breast cancer evidenced by mammography report (woman aged \> 40 years) for less than 12 months = BI-RADS1 or BI-RADS2
* Agreement not to use other hormones (estrogens, androgens and/or progestogens) in any pharmaceutical form during the study
Exclusion Criteria:
* Contraindications to the use of menopausal hormone therapy: Bleeding vaginal of unknown cause; personal history of hormone-dependent neoplasm including breast cancer, precursor lesions of breast cancer; liver disease; porphyria; personal history of coronary artery disease, cerebrovascular and venous thromboembolism; systemic lupus erythematosus with high thromboembolic risk and meningioma
* Comorbidities associated with increased cardiovascular risk: smoking, uncontrolled diabetes, dyslipidemia, and uncontrolled hypertension
* Serious chronic disorders, including metastatic malignancies, kidney disease in the end-stage with or without dialysis, clinically unstable heart disease, or any another disorder that, in the opinion of the investigator, excludes the participant from the study
* Immunocompromise or suspected or confirmed diagnosis of immunodeficiency based on history and/or physical or laboratory examination
* Active liver disease or dysfunction
* Benign or malignant tumors of the liver
* Clinical diagnosis of polycystic ovary syndrome
* Use of other hormones (estrogens, androgens and/or progestogens) in any pharmaceutical form in the last month
* Current use of drugs that alter cytochrome P450 and metabolization of Estrogens
* Current use of tamoxifen, aromatase inhibitors, or agonists/antagonists GnRH for cancer or any other condition
* Current use of phytoestrogens
* Participation in another clinical study within 30 days prior to the start of the Study treatment
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
41 Years
Maximum Age:
59 Years
Study:
NCT06136208
Study Brief:
Protocol Section:
NCT06136208