In an international multicentre trial of (DD) for treatment of CPP, a total of 76 patients, 68 girls and 8 boys, are presently enrolled. There are 50 (3 boys) naive patients (group I) and 26 (5 boys) who have been treated with either cyproterone acetate or Buserelin before (group I). Basal plasma LH (mlU/ml) decreased from 3.3 ± 0.3 (mean ± SE) and 2.8 ± 0.5 to 2.4 ± 0.3 and 1.6 ± 0.3 after 1 year of therapy in groups I and II, resp. The LH response to GnRH i.v. was signif. (p < 0.001) reduced in both groups from 45.1 ± 3.8 and 30 ± 6.4 mlU/ml to 4.2 ± 0.9 and 2.9 ± 0.9 mlU/ml. Similar results were obtained for FSH. Spontaneous nocturnal LH secretion was pulsatile before agonist therapy and prepubertally low after 3 or 6 months. At the same time, E2 levels fell signif. from 118 ± 12 to 52 ± 4 pmol/l (p < 0.01) in group and from 93 ± 22 to 36 ± 5 pmol/l in group II. Clinical signs of gonadarche showed either regression or complete arrest. Decapeptyl plasma levels determined by RIA after extraction showed a highly variable course after i.m. injection of DD, reaching maxinum levels between 30 and 120 min. 4 weeks after the last injection, DD plasma levels ranged from below sensitivity (30 pg/ml) to 567 pg/ml. There seemed to be no correlation between 4-week Decapeptyl levels and plasma E2. Except of short injection pain (anaesthetic spray helpful), no side effects were seen, we conclude that treatment of CPP with DD, given only every 4 weeks i.m., leads to an effective suppression of the pituitary-gonadal axis without clinical escapes, despite variable and sometimes very low plasma levels of the drug.
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