General Obstetrics and Gynecology GynecologyA randomized, double-blind, placebo-controlled, multicenter study that assessed the endometrial effects of norethindrone acetate plus ethinyl estradiol versus ethinyl estradiol alone☆,☆☆
Section snippets
Subjects
In total, 945 postmenopausal women were assigned randomly to receive treatment at 57 investigation centers. All centers obtained Institutional Review Board approval of the protocol and amendments, and written informed consent was obtained from each subject before enrollment in the study.
Inclusion and exclusion criteria
Women were eligible for treatment if they were ≥40 years old with an intact uterus, had undergone the onset of spontaneous or surgical menopause within 5 years of study enrollment, had been amenorrheic for at
Subject disposition and baseline patient characteristics
A total of 945 subjects were randomized to either the placebo group or one of the seven active treatment groups (Fig 1). No differences were observed in baseline demographics across the treatment groups (Table I).Characteristic Placebo 5 EE 0.25/5 NA/EE 1/5 NA/EE 10 EE 0.5/10 NA/EE 1/10 NA/EE CEE/MPA Overall Randomized to treatment (No.) 117 115 115 121 119 120 120 119 945 Age (y) 51.3 ± 3.9 51.5 ± 3.8 51.1 ± 4.3 51.6 ± 4.2 51.4 ± 4.2 51.4 ± 3.5 51.5 ± 3.8 51.4 ± 3.8 51.4 ± 3.9 Months since
Comment
Treatment with all NA/EE dose combinations that were evaluated in this study effectively prevented estrogen-induced endometrial hyperplasia. One case of hyperplasia occurred in the NA/EE treatment groups (0.25/5 NA/EE), and 1 case occurred in the placebo group. In addition, there was no change in endometrial proliferative status from baseline in postmenopausal women with an intact uterus. Biopsy severity scores for each NA/EE combination treatment group were significantly lower than in the
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2023, Phytochemistry LettersThe effect of 17β-estradiol plus norethisterone acetate treatment on the lipid profile in women: a dose-response meta-analysis of randomized controlled trials
2022, Experimental GerontologyCitation Excerpt :Thus, this decline in estrogen concentrations has a negative impact on the cardiometabolic system. The androgenic effect of NETA, a 19-nortestosterone derivative, can be countered by its combined administration with estrogens (E2) (Portman et al., 2003). In addition, the use of 17β-estradiol plus norethisterone acetate has also been reported to improve bone mass and density (Ishida et al., 2008), as well as to decrease visceral adiposity (Haarbo et al., 1991).
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2011, European Journal of Obstetrics and Gynecology and Reproductive BiologyCitation Excerpt :Endometrial hyperplasia was found after 12 months in one out of 94 patients in the 5 μg EE2 group [15]. In 2003, Portman et al. reported only one case of endometrial hyperplasia out of 114 at month 12 in the 5 μg EE2 group, an incidence similar to that observed in the placebo group (1/114 vs. 1/115) [22]. They did not report any case of endometrial pathology before month 12.
Sex hormones and related compounds, including hormonal contraceptives
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2016, Journal of Gynecologic Oncology
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Supported by Pfizer Global Research and Development.
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Reprint requests: David Portman, MD, Columbus Center for Women's Health Research, 5965 East Broad St, Suite 110, Columbus, OH 43213. E-mail: [email protected]