ENDOCRINE EFFECTS IN ASIAN POSTMENOPAUSAL WOMEN, TREATED WITH SH-D-461-M AND PREMPAK-C

We reported the results of a randomized cross-over study comparing SH D 461 M (Climen) and Prempak-C in 38 postmenopausal women who were est ablished users of hormone replacement therapy (HRT). Climen contains 1 1 tablets of 2 mg estradiol valerate (EV), and 10 tablets with 2 mg EV plus 1 mg of cyproterone acetate. Prempak-C, on the other hand, is a regimen consisting of 28 tablets of 0.625 mg conjugated equine estroge ns (CEE); the last 12 tablets are taken together with 0.15 mg of norge strel (NG) tablets. Patients in Sequence I started with Climen for 6 m onths and then crossed-over to Prempak-C, for the next 6 months. Patie nts in Sequence II followed the reverse order. Following Climen treatm ent, significantly higher levels (P < 0.05, t-test) of sex hormone bin ding globulin (SHBG) and estradiol, when compared to Prempak-C treated subjects, were noted. No significant differences in follicle stimulat ing hormone (FSH), corticosteroid binding globulin (CBG), renin, angio tensinogen, angiotensin-l and aldosterone levels between the two treat ment regimens were noted. While both regimens were effective in reduci ng menopausal symptoms, none of the regimens could eliminate all sympt oms completely. Treatment with Climen appeared to result in less frequ ent occurrences of some symptoms. During periods of no estrogen (only true for Climen) as well as periods of maximum P and E, subjects on Cl imen had significantly lower incidence of some of the symptoms (backac he, lack of concentration, lethargy and swelling) when compared to tho se on Prempak-C. The observed lower incidence of some symptoms during periods of no E in the Climen as compared to the Prempak-C regimens wo uld dispel the notion that an estrogen tablet-free interval would resu lt in more frequent occurrences of some menopausal symptoms. This obse rvation could be due, in part, to the higher estrogenicity of Climen, as indicated by higher SHBG levels following its treatment. Whether cy proterone acetate, which is non-androgenic and, in addition, anti-andr ogenic in comparison to norgestrel, has a part in improved symptom rel ief remains speculative.