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

An open‐label, prospective clinical study will be conducted to monitor serumconcentration and pharmacokinetic profiles following the subcutaneous implantation of sixsilicone hormone implants (delivering a total dose of 300 mg of estradiol) versus the useof transdermal estradiol gel (at a daily dose of 3.0 mg). Assessment of total serumestradiol concentration and determination of pharmacokinetic parameters will be performedin eligible participants before and after hormone implant insertion and transdermalestradiol gel use, at various sampling time points (within the first 24 hours, weeklyduring the first month, and monthly up to 6 full months). Additionally, theconcentrations of other hormones influenced by estradiol activity (total testosterone,estrone, FSH, LH, SHBG, and prolactin) will be determined. Medical consultations forclinical 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 thecrossover between hormone implant insertion and transdermal estradiol gel use.