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One-year endometrial safety evaluation of a continuous combined transdermal matrix patch delivering low-dose estradiol-norethisterone acetate in postmenopausal women

Maturitas, ISSN: 0378-5122, Vol: 57, Issue: 2, Page: 171-181
2007
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Metric Options:   Counts1 Year3 Year

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Article Description

To evaluate the safety and endometrial protection of low-dose transdermal estradiol (E2)/norethisterone acetate (NETA) patches (Estalis 25/125) in terms of post-treatment incidence of endometrial hyperplasia/cancer after 1 year of treatment in postmenopausal women with intact uteri. Patients were randomized to receive either transdermal E2/NETA (delivering daily doses of E2 25 μg and NETA 125 μg; applied every 3–4 days) or oral E2/NETA (E2 1 mg and NETA 0.5 mg; given daily) in this open-label study. The primary variable was the incidence of endometrial hyperplasia/cancer based on endometrial biopsies; secondary variables included vaginal bleeding/spotting patterns, patch adhesion, safety and tolerability. Six hundred and seventy-seven patients were randomized (507 in the transdermal group and 169 in the oral group; one did not receive study drug) and >80% completed the study. There were no cases of endometrial hyperplasia or cancer in either group and the upper limit of the one-sided 95% confidence interval in the transdermal group was 0.85%. Over time, both treatments were associated with a decreasing frequency of spotting/bleeding days. The overall incidence of adverse events (AEs) was comparable in both groups, and the majority was mild-to-moderate in intensity. Breast tenderness was the most frequently reported AE (transdermal 19.9% versus oral 28.4%). AEs related to the gastrointestinal system were more frequent with oral E2/NETA, and episodes of spotting and bleeding were more frequent with transdermal E2/NETA. Local skin tolerability of the transdermal matrix system was good. Transdermal E2/NETA (25 and 125 μg) provided adequate endometrial protection in postmenopausal women when evaluated according to CPMP/CHMP criteria, achieved a high rate of amenorrhea, and was well tolerated.

Bibliographic Details

Samsioe, Göran; Dvorak, Vladimir; Genazzani, Andrea R; Hamann, Bernd; Heikkinen, Jorma; Mueck, Alfred O; Suzin, Jacek; Kawakami, Fernando T; Ferreira, Alberto; Sun, Dongming; Arguinzoniz, Miguel

Elsevier BV

Biochemistry, Genetics and Molecular Biology; Medicine

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