Revistas Fase Ing Id Materia 4035


Objective: To evaluate the efficacy and tolerability of a continuous combined transdermal patch containing estradiol and norethisterone in postmenopausal women.

Methods: 40 patients were studied in a prospective, open-label, non-comparative study. The mean age was 56.7 years. Patients received a continuous combined transdermal patch containing estradiol-norethisterone for six months with an extension phase of one additional year. Menopausal Kupperman´s index was assessed, as well as clinical parameters (weight, blood pressure and endometrial thickness through transvaginal ultrasound) and reports related to adverse effects and skin changes after dermatological examination.

Results: The treatment was associated with global improvement in menopausal symptoms evaluated by Kupperman’s index. The in-depth analysis of moderate-severe symptoms showed significant improvement of hot flashes, sweating, paraesthesia, fatigue, irritability and emotional lability after three month of treatment, remaining stable until the end of the period of evaluation. Pruritus and erythema were the most common cutaneous events, occurring in 12.1% and 3.0% of patients, respectively. Mostly mild adverse events were observed.

Conclusion: Continuous combined estradiol-norethisterone transdermal patch was effective in symptomatic relief in postmenopausal women, with low rates of adverse events and good tolerability.