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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

PENTRAVAN - 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.

Study 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.

Eligibility

Primary outcome measure(s)

• hormonal implant and PENTRAVAN transdermal gel pharmacokinetics — 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).

Trial sites (1)

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