التفاصيل البيبلوغرافية
العنوان: |
Bleeding profile and endometrial safety of continuous combined regimens 1 mg 17β-estradiol/trimegestone versus 1 or 2 mg 17β-estradiol/norethisterone acetate in postmenopausal women. |
المؤلفون: |
Bouchard, P.1 (AUTHOR) philippe.bouchard@sat.ap-hop-paris.fr, De Cicco-Nardone, F.2 (AUTHOR), Spielmann, D.3 (AUTHOR), Garcea, N.4 (AUTHOR), The Trimegestone 301 Study Group1 (AUTHOR) |
المصدر: |
Gynecological Endocrinology. Sep2005, Vol. 21 Issue 3, p142-148. 7p. 1 Diagram, 4 Charts, 3 Graphs. |
مصطلحات موضوعية: |
*MENOPAUSE, *HEMORRHAGE, *MENSTRUAL cycle, *ENDOCRINE gynecology, *DRUG efficacy, *CLINICAL trials |
مستخلص: |
Objective . To compare the bleeding profile and endometrial safety of continuous combined 1 mg 17β-estradiol (17β-E 2 ) and 0.125 mg trimegestone (TMG) with those of two continuous combined 17β-E 2 and norethisterone acetate (NETA) regimens. Study design . This was a double-blind, randomized, multicenter study conducted in 12 European countries and Israel over a 2-year period. Healthy postmenopausal women with an intact uterus were given either 1 mg 17β-E 2 /0.125 mg TMG, 2 mg 17β-E 2 /1 mg NETA or 1 mg 17β-E 2 /0.5 mg NETA for up to 26 cycles, each of 28 days. Results . The percentage of amenorrheic women was greater in most cycles up to cycle 13 in the 1 mg 17β-E 2 /0.125 mg TMG group than in the comparator groups. The mean number of bleeding days was similar in the 1 mg 17β-E 2 /0.125 mg TMG and the 1 mg 17β-E 2 /0.5 mg NETA groups, but greater in the 2 mg 17β-E 2 /1 mg NETA group. No endometrial hyperplasia was observed for any group. Conclusion . Continuous combined 1 mg 17β-E 2 /0.125 mg TMG exhibits a more favorable bleeding profile than 1 mg 17β-E 2 /0.5 mg NETA up to 1 year, while providing an adequate protective effect on the endometrium. [ABSTRACT FROM AUTHOR] |
قاعدة البيانات: |
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