SPLENO-PEPTIDES FOR CLIMACTERIC COMPLAINT S - COMPARATIVE-STUDIES OF OVARIES STIMULATION VS TRANSDERMAL ESTRADIOL SUBSTITUTION

256 women aged 45 to 60 years with climacteric complaints participated in an open randomized clinical study comparing spleno-peptides (SPS 1 187, Solcosplen(R)) with transdermal estrogen (CAS 50-28-2, E(2)) subs titution (4 mg) in respect of efficacy and tolerability. The primary c riterion, defined as the Kupperman Index, and the safety parameter of the drugs were estimated prior to and after 1, 4 and 8 weeks of therap y. In the pre-, peri- and early postmenopause the results of treatment with the spleno-peptides were comparable to those with transdermal E( 2) substitution (4 mg). Pre-treatment with estrogens impaired the resu lts of treatment significantly. Although the menopausal status (in mos t cases < 3 years) did not influence the results essentially, the effi cacy of SPS 1187 is expected to decrease 2 to 3 years postmenopause. T herefore SPS 1187 should be used in pre-, peri- and early postmenopaus e only. The tolerance of SPS 1187 was found to be significantly better than that of the E(2) patch. With respect to the claimed indication, i.e. climacteric complaints in the pre-, peri- and early postmenopause , SPS 1187 having an equivalent efficacy compared to that of the E(2) patch shows a better tolerability (total collectives) and better benef it/risk ratio.