Pharmacokinetic Aspects of 25-mg Estradiol Pellet in Climacteric Women Comprehensive Longitudinal Assessment of Release With Estradiol Pellet Analysis (CLARA Study)

CLARA Study

A multicenter, prospective, open-label clinical study will be conducted, to monitor serum concentration and pharmacokinetic profile after subcutaneous implantation of a 25mg absorbable pellet containing estradiol in climacteric women.

2023-12-13

2024-10-30

2024-10-30

Recruiting

25

Inclusion Criteria: * Signed Informed Consent Form * Woman aged ≥ 41 and ≤ 59 years * Weight ≥ 50 kg and ≤ 90 kg- BMI ≥ 18.5 and ≤ 34.9 kg/m² * Hysterectomy (with or without oophorectomy) * Hypoestrogenism defined by serum total estradiol concentration ≤ 50 pg/mL and serum FSH concentration ≥ 25 mIU/mL * Women with climacteric 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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ESTIMATED'}}

2024-03-20