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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.

Samsioe, Göran LU ; Dvorak, Vladimir; Genazzani, Andrea R; Hamann, Bernd; Heikkinen, Jorma; Mueck, Alfred O; Suzin, Jacek; Kawakami, Fernando T; Ferreira, Alberto and Sun, Dongming, et al. (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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published
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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
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yes
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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
2007-07-24 09:38:42
date last changed
2017-01-01 05:17:36
@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},
  volume       = {57},
  year         = {2007},
}