Back to Search
Start Over
Ultra-low-dose continuous combined estradiol and norethisterone acetate: improved bleeding profile in postmenopausal women.
- Source :
-
Climacteric . Feb2008, Vol. 11 Issue 1, p63-73. 11p. 1 Diagram, 2 Charts, 6 Graphs. - Publication Year :
- 2008
-
Abstract
- 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. [ABSTRACT FROM AUTHOR]
- Subjects :
- *ESTRADIOL
*NORETHINDRONE
*MENOPAUSE
*ENDOMETRIUM
*HORMONE therapy
*PLACEBOS
Subjects
Details
- Language :
- English
- ISSN :
- 13697137
- Volume :
- 11
- Issue :
- 1
- Database :
- Academic Search Index
- Journal :
- Climacteric
- Publication Type :
- Academic Journal
- Accession number :
- 28444673
- Full Text :
- https://doi.org/10.1080/13697130701852390