TREATMENT OF ENDOMETRIOSIS WITH THE GNRH AGONIST BUSERELIN (SUPRECUR(R)) - A MULTICENTRIC STUDY

A phase III multicentre study was carried out with the GnRH agonist bu serelin (Suprecur(R)) at five university institutions (Dept. of Obstet rics and Gynaecology of Essen, Kiel, Tubingen, Munster and Erlangen) t o evaluate the effect of Buserelin (3 x 300 mu g daily intranasal) on endometriosis for a period of 6 months. Endometriosis was verified by Light microscopy in all cases. The data of 430 patients could be evalu ated. The extent of the endometriotic lesions was studied before the s tart and at the end of therapy. The mean age of the patients was 30 +/ - 5 years. For 300 patients (66.4 %) sterility was a main problem. Pre vious treatment for endometriosis consisted of operation in 20.5 %, tr eatment with danazol in 16.8 % and treatment with gestagens in 11.6 % of the patients. Under treatment FSH changed from 11.0 +/- 31.4 mIU/ml to 7.0 +/- 5.6 mIU/ml at the end of therapy; LH from 11.1 +/- 12.9 mI U/ml to 7.4 +/- 7.3 mIU/ml; estradiol from 113.9 +/- 89.0 to 35.9 +/- 60.3 pg/ml and progesterone from 7.2 +/- 11.2 ng/ml to 0.8 +/- 1.4 ng/ ml. The effect on endometriosis was judged according to the revised Am erican Fertility Society score (rAFS 1985)(1). The changes of the rAFS -score stages were as follows (before/after therapy): Stage 0: 0 %/42. 8 %; stage I: 43.5 %/38.5 %; stage II: 31.1 %/11.2 %; stage III: 18.1 %/2.2 %; stage IV: 6.3 %/0.2 %. The total mean AFS-stage changed from 1.9 to 0.7. The frequency of clinical symptoms improved (before/after therapy): dysmenorrhoea 65.0 %/11.2 %; pelvic pain 48.2 %/14.1 %; pain at the time of gynaelogical examination 40.0 %/9.7 %. The following s ide effects were recorded: hot flashes 61.7 % of all cases, headache i n 20.0 %, vaginal dryness in 17.9 %, sleeplesness in 17.5 %, decrease of libido in 7.9 %, gastrointestinal discomfort in 6.3 %, depression i n 6.3 % and breast atrophy in 5.6 %. 26 safety parameters remained wit hin the normal range. It is notewothy that a significant increase in H DL-cholesterol was observed as well as a rise of the HDL/LDH ratio. Th is large-scale clinical study demonstrates the value and effectiveness of Buserelin intranasal spray for the reduction of endometriotic lesi ons and effective ameloriation of clinical symptoms.