Efficacy on climacteric symptoms of a continuous combined regimen of 1 mg 17beta-estradiol and trimegestone versus two regimens combining 1 or 2 mg 17beta-estradiol and norethisterone acetate.
OBJECTIVE
To compare the efficacy of a continuous combined regimen of 1mg 17beta-estradiol (17beta-E2) and 0.125 mg trimegestone (TMG) with two continuous combined 17beta-E2/norethisterone acetate (NETA) combinations in the relief of climacteric symptoms in postmenopausal women.


METHODS
This was a randomized, double-blind, multicenter study conducted in 13 countries over a 2-year period. Healthy postmenopausal women with an intact uterus were treated with 1 mg 17beta-E2/0.125 mg TMG, 2 mg 17beta-E2/1 mg NETA or 1 mg 17beta-E2/0.5 mg NETA for up to 26 cycles, each of 28 days.


RESULTS
The 1 mg 17beta-E2/0.125 mg TMG combination was effective in significantly reducing the mean daily number and severity of hot flushes and in reducing the number of night sweats from cycle 1 onward. No overall significant differences between this regimen and the comparators were detected. Other efficacy variables, including the Kupperman index, psychofunctional disorders and quality-of-life sub-scales, experienced a similar improvement from baseline with all treatments.


CONCLUSIONS
Continuous combined 1 mg 17beta-E2/0.125 mg TMG provides relief of menopausal symptoms that is non-inferior to both 17beta-E2/NETA combinations. Furthermore, trimegestone appeared to provide a better improvement of depressive mood than 0.5 mg NETA when combined with 1 mg 17beta-estradiol.
Gambacciani
M
M
Dept. of Obstetrics and Gynecology, Piero Fioretti University of Pisa, Via Roma 67, I-56100 Pisa, Italy. margamba@tin.it
Spielmann
D
D
Genazzani
A R
AR
D000284:Administration, Oral; D000328:Adult; D000339:Affect / Q000187:drug effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004958:Estradiol / Q000008:administration & dosage / Q000627:therapeutic use*; D015914:Estrogen Replacement Therapy / Q000379:methods; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077563:Norethindrone Acetate; D017698:Postmenopause / Q000187:drug effects*; D011397:Promegestone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011446:Prospective Studies; D011788:Quality of Life; D013546:Sweating / Q000187:drug effects
D004338:Drug Combinations; C050319:trimegestone; D004958:Estradiol; D000077563:Norethindrone Acetate; D011397:Promegestone; D009640:Norethindrone