[Splenopeptides for climacteric complaints. Comparison of ovarian stimulation with transdermal estradiol substitution].
256 women aged 45 to 60 years with climacteric complaints participated in an open randomized clinical study comparing spleno-peptides (SPS 1187, Solcosplen) with transdermal estrogen (CAS 50-28-2, E2) substitution (4 mg) in respect of efficacy and tolerability. The primary criterion, defined as the Kupperman Index, and the safety parameter of the drugs were estimated prior to and after 1, 4 and 8 weeks of therapy. In the pre-, peri- and early postmenopause the results of treatment with the spleno-peptides were comparable to those with transdermal E2 substitution (4 mg). Pretreatment with estrogens impaired the results of treatment significantly. Although the menopausal status (in most cases < 3 years) did not influence the results essentially, the efficacy of SPS 1187 is expected to decrease 2 to 3 years postmenopause. Therefore SPS 1187 should be used in pre-, peri- and early postmenopause only. The tolerance of SPS 1187 was found to be significantly better than that of the E2 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 E2 patch shows a better tolerability (total collectives) and better benefit/risk ratio.
Lauritzen
C
C
Forschungsinstitut für Gynäkologische Endokrinologie, Menopause und Sterilität, Ulm.
Teucher
T
T
Schmitz
H
H
D000279:Administration, Cutaneous; D000328:Adult; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002979:Climacteric / Q000187:drug effects*; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause / Q000187:drug effects; D014020:Tissue Extracts / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000924:Anticholesteremic Agents; C083458:Solcosplen; D014020:Tissue Extracts; D004958:Estradiol
Spleno-Peptide bei klimakterischen Beschwerden. Vergleichende Untersuchung einer ovariellen Stimulation mit transdermaler Estradiol-Substitution.