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Climacteric. 2008 Feb;11(1):63-73.
Ultra-low-dose continuous combined estradiol and norethisterone
acetate: improved bleeding profile in postmenopausal women.
Sturdee DW, Archer DF, Rakov V, Lang E, Investigators OB.
Department of Obstetrics and Gynecology, Solihull Hospital,
Solihull, West Midlands, UK.
Objective To evaluate the effect of two ultra-low-dose hormone
treatments containing estradiol (E2) 0.5 mg and norethisterone
acetate (NETA) 0.1 or 0.25 mg on the endometrium and bleeding.
Methods A prospective, randomized, placebo-controlled trial of 6
months. Local Ethics Committee approval and informed consent
were obtained prior to initiation and enrolment. Out of 577
postmenopausal women randomized, 575 took E2/NETA 0.1 (n = 194),
or E2/NETA 0.25 (n = 181) or placebo (n = 200). Endometrial
bleeding was monitored by daily diary cards and endometrial
thickness by transvaginal ultrasound at baseline and on
completion. An endometrial biopsy was obtained when indicated
clinically. Results In months 1-6, the amenorrhea rates with E2/NETA
0.1 were 89%, 89%, 86%, 85%, 89% and 89%, respectively and the
no-bleeding rates were correspondingly high: 95%, 94%, 93%, 90%,
95% and 95%. The amenorrhea and spotting-only rates were similar
with both ultra-low-dose combinations. The withdrawal rates due
to bleeding were very low and the same in all three treatment
arms (n = 1; 1%). There was a slight increase in the mean
endometrial thickness in all three groups, which remained less
than 5 mm. Conclusions The ultra-low-dose combination of E2/NETA
0.1 or E2/NETA 0.25 resulted in a high incidence of amenorrhea
and no bleeding in postmenopausal women, and a corresponding
high level of compliance. Overall, there was no significant
change in mean endometrial thickness during 6 months of active
treatment or placebo.
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