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NCT07754630

PHASE2

Analysis of the Hormonal Implant and Transdermal Estradiol Gel in Climacteric Women

Sponsor: Nutrindo Ideais Research Center

View on ClinicalTrials.gov

Summary

An open-label, prospective clinical study will be conducted to monitor serum concentration and pharmacokinetic profiles following the subcutaneous implantation of six silicone hormone implants (delivering a total dose of 300 mg of estradiol) versus the use of transdermal estradiol gel (at a daily dose of 3.0 mg). Assessment of total serum estradiol concentration and determination of pharmacokinetic parameters will be performed in eligible participants before and after hormone implant insertion and transdermal estradiol gel use, at various sampling time points (within the first 24 hours, weekly during the first month, and monthly up to 6 full months). Additionally, the concentrations of other hormones influenced by estradiol activity (total testosterone, estrone, FSH, LH, SHBG, and prolactin) will be determined. Medical consultations for clinical assessment and participant follow-up will be conducted at baseline and at 1, 3, and 6 months. The primary outcome assessment will be performed 6 months after the crossover between hormone implant insertion and transdermal estradiol gel use.

Official title: Comparison Between the Silastic Hormonal Implant and Transdermal Estradiol Gel in Climacteric Women: a Randomized Controlled Clinical Trial

Key Details

Gender

FEMALE

Age Range

41 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-02-25

Completion Date

2027-10-01

Last Updated

2026-08-10

Healthy Volunteers

Conditions

Menopause Hypoestrogenism Hormonal Therapy

Interventions

DRUG

implantable estradiol

The assessment will include medical history, a physical examination, routine screening laboratory tests, a mammogram, and, when necessary, a transvaginal ultrasound. Each subject's body weight, height, and blood pressure will be recorded by an investigator. Subsequently, each of the 50 women will receive six (6) estradiol implants, each with a dose of 50 mg, totaling 300 mg (Elmeco, Salvador, Brazil). Each implant (40 mm in diameter) will be inserted subcutaneously into the buttock under local anesthesia. Following insertion, the patient will remain under observation at the clinic for the collection of multiple blood samples; these will be taken prior to the insertion of the Silastic implants and at 2, 4, 6, 8, 10, and 12 hours post-insertion. Patients will be instructed regarding their follow-up visits, which are scheduled for 24 hours, 7 days, 14 days, 21 days, 28 days, 56 days, 84 days, 112 days, 140 days, and 168 days.

DRUG

OESTROGEL - transdermal gel

Medical consultations for clinical assessment will be conducted, involving the completion of a questionnaire on menopausal symptoms and participant follow-up at baseline (t0) and at 1, 3, and 6 months. The Menopause Rating Scale (MRS) (Heinemann et al., 2004) will be used for the questionnaire. During all follow-up visits, volunteers will undergo a physical examination, including a breast exam; measurements of blood pressure, weight, body mass index (BMI), and hip and waist circumferences; and bioimpedance analysis.

DRUG

PENTRAVAN - transdermal gel

Inclusion Criteria: Women aged 41 to 59 years with climacteric symptoms, weighing 50 to 90 kg, with a BMI of 18.5 to 34.9 kg/m². Hysterectomy (with or without oophorectomy). Hypoestrogenism defined by a total serum estradiol concentration ≤ 50 pg/mL and a serum FSH concentration ≥ 25 mIU/mL. Absence of signs, symptoms, or clinical findings suggestive of breast cancer, as evidenced by a mammography report (for women \> 40 years of age) dated within the last 12 months showing BI-RADS 1 or BI-RADS 2 classification. Agreement not to use other hormones (estrogens, androgens, and/or progestogens) or contraceptives in any pharmaceutical form during the study. Exclusion Criteria: Contraindications to the use of menopausal hormone therapy: vaginal bleeding of unknown cause; personal history of hormone-dependent neoplasia, including breast cancer or breast cancer precursor lesions; liver disease; porphyria; personal history of coronary artery disease, cerebrovascular disease, or venous thromboembolism; systemic lupus erythematosus with high thromboembolic risk; and meningioma. Comorbidities associated with increased cardiovascular risk: smoking, uncontrolled diabetes, dyslipidemia, and uncontrolled hypertension. Severe chronic disorders, including metastatic malignancies, end-stage renal disease (with or without dialysis), clinically unstable heart disease, or any other disorder that, in the investigator's opinion, excludes the participant from the study. Immunocompromise or suspected/confirmed diagnosis of immunodeficiency based on history and/or physical or laboratory examination. Active liver disease or dysfunction. Benign or malignant liver tumors. Clinical diagnosis of polycystic ovary syndrome. Use of other hormones (estrogens, androgens, and/or progestogens) in any pharmaceutical form within the last month. Use of contraceptives. Current use of medications that alter cytochrome P450 activity and estrogen metabolism. Current use of tamoxifen, aromatase inhibitors, or GnRH agonists/antagonists for cancer or any other condition. Current use of phytoestrogens. Participation in another clinical study within 30 days prior to the start of study treatment. Patients who do not complete all study stages, who do not adhere to the intervention, or who experience an intercurrent event that interferes with the study outcome. \-

Locations (1)

Nutrindo Ideais Research Center

Rio de Janeiro, Rio de Janeiro, Brazil

Clinical Research Directory

Analysis of the Hormonal Implant and Transdermal Estradiol Gel in Climacteric Women

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)