One-year endometrial safety evaluation of a continuous combined transdermal matrix patch delivering low-dose estradiol-norethisterone acetate in postmenopausal women.
(2007) In Maturitas 57. p.171-181- Abstract
- Objective: 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 endornetrial hyperplasia/cancer after 1 year of treatment in postmenopausal women with intact uteri. Methods: Patients were randomized to receive either transdermal E2/NETA (delivering daily doses of E2 25 mu g and NETA 125 mu g; 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. Results:... (More)
- Objective: 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 endornetrial hyperplasia/cancer after 1 year of treatment in postmenopausal women with intact uteri. Methods: Patients were randomized to receive either transdermal E2/NETA (delivering daily doses of E2 25 mu g and NETA 125 mu g; 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. Results: 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. Conclusions: Transdermal E2/NETA (25 and 125 1 mu g) provided adequate endometrial protection in postmenopausal women when evaluated according to CPMP/CHMP criteria, achieved a high rate of amenorrhea, and was well tolerated. (Less)
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- author
- organization
- publishing date
- 2007
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Maturitas
- volume
- 57
- pages
- 171 - 181
- publisher
- Elsevier
- external identifiers
-
- wos:000247408200007
- scopus:34247118368
- ISSN
- 1873-4111
- DOI
- 10.1016/j.maturitas.2007.01.001
- language
- English
- LU publication?
- yes
- id
- 2ec94e81-39de-4e14-864c-0d9db1212a17 (old id 165477)
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- http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=17317046&dopt=Abstract
- date added to LUP
- 2016-04-01 12:36:23
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- 2022-04-06 00:38:12
@article{2ec94e81-39de-4e14-864c-0d9db1212a17,
abstract = {{Objective: 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 endornetrial hyperplasia/cancer after 1 year of treatment in postmenopausal women with intact uteri. Methods: Patients were randomized to receive either transdermal E2/NETA (delivering daily doses of E2 25 mu g and NETA 125 mu g; 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. Results: 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. Conclusions: Transdermal E2/NETA (25 and 125 1 mu g) provided adequate endometrial protection in postmenopausal women when evaluated according to CPMP/CHMP criteria, achieved a high rate of amenorrhea, and was well tolerated.}},
author = {{Samsioe, Göran and Dvorak, Vladimir and Genazzani, Andrea R and Hamann, Bernd and Heikkinen, Jorma and Mueck, Alfred O and Suzin, Jacek and Kawakami, Fernando T and Ferreira, Alberto and Sun, Dongming and Arguinzoniz, Miguel}},
issn = {{1873-4111}},
language = {{eng}},
pages = {{171--181}},
publisher = {{Elsevier}},
series = {{Maturitas}},
title = {{One-year endometrial safety evaluation of a continuous combined transdermal matrix patch delivering low-dose estradiol-norethisterone acetate in postmenopausal women.}},
url = {{http://dx.doi.org/10.1016/j.maturitas.2007.01.001}},
doi = {{10.1016/j.maturitas.2007.01.001}},
volume = {{57}},
year = {{2007}},
}