A study of the control of climacteric symptoms in postmenopausal women following sequential regimens of 1 mg 17beta-estradiol and trimegestone compared with a regimen containing 1 mg estradiol valerate and norethisterone over a two-year period.
OBJECTIVE
To compare the efficacy of two sequential 17beta-estradiol (17beta-E2)/trimegestone (TMG) combinations with the sequential estradiol valerate (E2V)/norethisterone (NET) regimen in relieving climacteric symptoms.


METHODS
This was a double-blind, randomized, multicenter study conducted among 1218 Caucasian (99%) postmenopausal women with an intact uterus in seven European countries and Israel, over 13 cycles (each of 28 days). Study duration was extended further for 13 cycles, with 531 women receiving treatment for up to 26 cycles. Treatments consisted of 1 mg 17beta-E2 on days 1-14 and 1 mg 17beta-E2/0.125 mg TMG or 0.25 mg TMG on days 15-28, and 1 mg E2V on days 1-16 and 1 mg E2V/1 mg NET on days 17-28.


RESULTS
Rapid and significant reductions in the mean daily number and severity of hot flushes and in the mean daily number of nocturnal sweats were established in most women with 1 mg 17beta-E2/0.25 mg TMG and E2V/NET. These treatments also induced a significant improvement in the quality-of-life assessments.


CONCLUSIONS
The 1 mg 17beta-E2/0.25 mg TMG regimen provides rapid and effective relief of menopausal symptoms, with a reduction in the number of hot flushes "at least as good as" that of the E2V/NET comparator.
Pornel
B
B
Department of Gynaecology, Brussels Menopause Center, Avenue Winston Churchill 239, B-1180 Brussels, Belgium. bruno.pornel@menopausecenter.be
Spielmann
D
D
D000284:Administration, Oral; D000328:Adult; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D015914:Estrogen Replacement Therapy / Q000009:adverse effects / 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; D012893:Sleep Wake Disorders / Q000188:drug therapy; D013546:Sweating / Q000187:drug effects; D014592:Uterine Hemorrhage / Q000139:chemically induced
D004338:Drug Combinations; C050319:trimegestone; D004958:Estradiol; D000077563:Norethindrone Acetate; D011397:Promegestone; D009640:Norethindrone