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 regime consisting of 28 tablets of 0.625 mg conjugated equine estrogen s (GEE); the last 12 tablets are taken together with 0.15 mg of norges trel (NG) tablets. Patients in Sequence I started with Climen for 6 mo nths and then crossed-over to Prempak-C, for the next 6 months; patien ts 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-I and aldosterone levels between the two treat ment regimes were noted, While both regimes were effective in reducing menopausal symptoms, none of the regimes could eliminate all symptoms completely. Treatment with Climen appeared to result in less frequent occurrences of some symptoms. During periods of no estrogen (only tru e for Climen) as well as periods of maximum progestagen and estrogen ( P and E), subjects on Climen had significantly lower incidence of some of the symptoms (backache, lack of concentration, lethargy and swelli ng) when compared to those on Prempak-C. The observed lower incidence of some symptoms during periods of no estrogen in the Climen as compar ed to the Prempak-C regimes would dispel the notion that an estrogen t ablet-free interval would result in more frequent occurrences of some menopausal symptoms. This observation could be due, in part, to the hi gher estrogenicity of Climen, as indicated by higher SHBG levels follo wing its treatment. Whether cyproterone acetate, which is non-androgen ic and, in addition, anti-androgenic as compared to norgestrel, has a part in better symptom relief remains speculative.