Endocrine effects in asian postmenopausal women, treated with SH D 461 M and Prempak-C

Abstract

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 established users of hormone replacement therapy (HRT). Climen contains II tablets of 2 mg estradiol valerate (EV). and 10 tablets with 2 mg EV plus I mg of cyproterone acetate. Prempak-C, on the other hand, is a regimen consisting of 28 tablets of 0.625 mg conjugated equine estrogens (CEE); the last 12 tablets are taken together with 0.15 mg of norgestrel (NG) tablets. Patients in Sequence I started with Climen for 6 months and then crossed-over to Prempak-C, for the next 6 months. Patients in Sequence II followed the reverse order. Following Climen treatment, significantly higher levels (P < 0.05, t-test) of sex hormone binding globulin (SHBG) and estradiol, when compared to Prempak-C treated subjects, were noted. No significant differences in follicle stimulating hormone (FSH), corticosteroid binding globulin (CBG), renin, angiotensinogen, angiotensin-l and aldosterone levels between the two treatment regimens were noted. While both regimens were effective in reducing menopausal symptoms, none of the regimens could eliminate all symptoms completely. Treatment with Climen appeared to result in less frequent occurrences of some symptoms. During periods of no estrogen (only true for Climen) as well as periods of maximum P and E, subjects on Climen had significantly lower incidence of some of the symptoms (backache, lack of concentration, lethargy and swelling) when compared to those 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 would dispel the notion that an estrogen tablet-free interval would result in more frequent occurrences of some menopausal symptoms. This observation could be due, in part, to the higher estrogenicity of Climen, as indicated by higher SHBG levels following its treatment. Whether cyproterone acetate, which is non-androgenic and, in addition, anti-androgenic in comparison to norgestrel, has a part in improved symptom relief remains speculative.