A double-blind, randomized, comparative study evaluating clinical effects of two sequential estradiol-progestogen combinations containing either desogestrel or medroxyprogesterone acetate in climacteric women

Objectives: The aim of this study was to compare a new sequential estradiol -desogestrel (E-2-DSG) hormone replacement regimen (Liseta(R)) with one of the standard treatments i.e. estradiol valerate-medroxyprogesterone acetate (E2V-MPA) combination (Klimalet(R)) regarding the alleviation of climacter ic symptoms, vaginal bleeding pattern and the occurrence of adverse experie nces. Methods: In a multicenter study performed in Denmark, a total of 376 perimenopausal women with climacteric symptoms were randomly allocated to o ral sequential treatment with either E-2-DSG (1.5 mg E-2 for 24 days with 0 .15 mg DSG for the last 12 days followed by a placebo tablet fbr 4 days) (n = 186) or with E2V-MPA (2 mg E2V for 21 days with 10 mg MPA for the last 1 0 days) (n = 190). Treatments were administered, using a double-blind, doub le-dummy technique for 6 cycles of 28 days. Results: Three hundred and seve nteen women, 158 in the E-2-DSG and 159 in the E2V-MPA group, completed six treatment cycles. Both treatments reduced menopausal symptoms rapidly and to a similar extent. Hot flushes were present in 88% of the women in both g roups. After six treatment cycles, hot flushes were no longer present in 71 and 62% of the women in the E-2-DSG and E2V-MPA group, respectively. Persp iration decreased from 80 to 65% in the E-2-DSG group and from 82 to 63% in the E2V-MPA group. Mood disturbances were present in 82% of the women in t he E-2-DSG at baseline, and in 52% after six cycles. In the E2V-MPA group t he corresponding figures were 68 and 42%, respectively. The bleeding patter n was comparable in both treatment groups. Regular withdrawal (expected) bl eeding appeared in 90-92% and in 85-90% of the women in cycles 1-5 with E-2 -DSG and E2V-MPA, respectively. Irregular bleeding (including spotting) occ urred in 15.2% of the women receiving E-2-DSG and in 20.1% of the women tre ated with E2V-MPA in cycle 6. In both treatment groups there was a tendency of a slight decrease in blood pressure:. Adverse events were in less than 10% in each group the reason to discontinue treatment. Conclusions: Both tr eatments effectively alleviated menopausal complaints and presented good cy cle control. Bleeding pattern and mood disturbances appeared to be more fav orable influenced by E-2-DSG. (C) 2000 Elsevier Science Ireland Ltd. All ri ghts reserved.