A RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY COMPARING THE CLINICAL EFFECTS OF 2 SEQUENTIAL ESTRADIOL-PROGESTIN COMBINATIONS CONTAINING EITHER DESOGESTREL OR NORETHISTERONE ACETATE IN CLIMACTERIC WOMEN WITH ESTROGEN DEFICIENCY SYMPTOMS

Objectives: The aim of this study was to compare a new estradiol-desog estrel (E(2)-DG) regimen with an E(2)-norethisterone acetate (NETA) co mbination (Trisekvens(R)) regarding the treatment of menopausal compla ints, bleeding pattern, histology of the endometrium and the occurrenc e of adverse experiences. Methods: A total of 310 peri-/postmenopausal women with climacteric symptoms were randomly allocated to oral seque ntial treatment with either the E(2)-DG combination (1.5 mg E(2) for 2 4 days with 0.15 mg DG for the last 12 days followed by 1 placebo tabl et for 4 days) or with the E(2)-NETA combination (Trisekvens(R), 2 mg E(2) for 22 days with 1 mg NETA for the last 10 days followed by 1 mg E(2) for 6 days). Treatments were administered double-blind for 12 cyc les of 28 days. Results: One hundred and four women, 48 in the E(2)-DG group and 56 in the E(2)-NETA group, discontinued the study due to bl eeding irregularities and various adverse effects. Both treatments red uced menopausal symptoms and complaints effectively and almost equally . The alleviation of perspirations and the improvement of general fitn ess were more apparent (P = 0.009) during cycle 1 with the E(2)-NETA t reatment but were greater (P < 0.02) during the last 9/10-12 cycles of E(2)-DG treatment compared to E(2)-NETA. Regular withdrawal bleeding appeared in 93% and 90% of the women during treatment with E(2)-DG and E(2)-NETA, respectively. Intermenstrual bleeding occurred in 8% of wo men receiving E(2)-DG and in 13% of women treated with E(2)-NETA. The corresponding figures for intermenstrual bleeding-spotting were 21% an d 22%. Secretory endometrium was detected in 65% and 54% of the sample s taken at the end of treatment with E(2)-DG and E(2)-NETA, respective ly. No hyperplasia or atypia was found. No serious adverse events rela ted to treatment occurred. Conclusions: Both regimens alleviated effec tively menopausal complaints and did not induce hyperplasia of endomet rium. The minor differences recorded between the two regimens were pro bably due to the differences in their composition concerning the amoun t of estradiol and its distribution along the cycle, the amount and ty pe of progestin and the length of estradiol/progestin combination phas e.