Comparison Between the Silastic Hormonal Implant and Transdermal Estradiol Gel in Climacteric Women: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- hormonal implant and PENTRAVAN transdermal gel pharmacokinetics
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 41 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
IMPLANT
For the 50 patients, the placement and removal of the gluteal implants will be performed by a single physician from the clinic to ensure study standardization. All patients will receive post-implant instructions, including keeping the dressing in place for 5 days. After this period, the dressing should be removed, and the patient may bathe normally, lathering and rinsing the area and drying it carefully afterward. Following the bath, 70% alcohol should be applied and allowed to air dry. Participants must refrain from physical activity for 3 days after implant placement. Participants will be instructed to apply an ice pack for 15 minutes in the hours following the procedure and to continue this measure over the subsequent days if local swelling occurs. The initial assessment will include medical history, a physical examination, routine screening laboratory tests, mammography, and, when necessary, transvaginal ultrasound.
干预措施: implantable estradiol (Drug)
PENTRAVAN
The 25 volunteers in the group will follow the same protocol, except for the use of the 3.0 mg PENTRAVAN compounded estradiol gel, which must be applied daily in the morning to clean skin on the arm or leg after bathing; the gel must not be mixed with other creams or similar products.
干预措施: PENTRAVAN - transdermal gel (Drug)
OESTROGEL
The 25 volunteers in the group will follow the same protocol, except for the use of the 3.0 mg OESTROGEL estradiol gel, which must be applied daily in the morning to clean skin on the arm or leg after bathing; the gel must not be mixed with other creams or similar products.
干预措施: OESTROGEL - transdermal gel (Drug)
结局指标
主要结局
hormonal implant and PENTRAVAN transdermal gel pharmacokinetics
时间窗: From enrollment to the end of treatment at 168 days
Assessment of total serum estradiol concentration (silastic implant versus transdermal gel). Multiple blood samples will be collected at 0, 2, 4, 6, 8, 10, 12, and 24 hours; and at 7, 14, 21, 28, 56, 84, 112, 140, and 168 days, and will be analyzed using liquid chromatography (LC-MS/MS).
次要结局
- menopausal symptoms(From enrollment to the end of treatment at 168 days)