Status:
COMPLETED
Pharmacokinetic Aspects of 25-mg Estradiol Pellet in Climacteric Women
Lead Sponsor:
Science Valley Research Institute
Collaborating Sponsors:
Biòs Farmacêutica
Conditions:
Climacteric Syndrome
Menopause
Eligibility:
FEMALE
41-59 years
Phase:
NA
Brief Summary
A single center, prospective, open-label clinical study will be conducted, to monitor serum concentration and pharmacokinetic profile after subcutaneous implantation of a 25mg-estradiol bioabsorbable ...
Detailed Description
Assessing serum total estradiol concentration and determination of pharmacokinetic parameters will be performed in participants eligible for the study before and after the insertion of estradiol pelle...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06136208
Start Date
December 13 2023
End Date
July 30 2025
Last Update
September 8 2025
Active Locations (1)
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1
Irmandade Da Santa Casa De Misericórdia De Santos - Science Valley Research Center
Santos, São Paulo, Brazil, 11075-900