Pharmacokinetic Aspects of 25-mg Estradiol Pellet in Climacteric Women

• Status: Recruiting
• Trial end date: 2024-10-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Science Valley Research Institute
• Collaborator: Biòs Farmacêutica
• Treatments: Estradiol

Criteria

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