STEROIDAL ADD-BACK THERAPY IN PATIENTS TREATED WITH GNRH AGONISTS

GnRH analogues (GnRH-a) are well established in the treatment of endom etriosis. However, due to hypooestrogenic effects: treatment is limite d to 6 months. The aim of this randomized, double-blind, comparative s tudy was to evaluate whether symptoms and signs of hypooestrogenism, e .g. hot flushes, sweating and sleeplessness, could be avoided by a ste roidal add-back regimen, while the beneficial effect of a GnRH-a on en dometriosis could be maintained. Ln group A, 14 patients were treated with 3.75 mg leuprorelin acetate depot per month i.m. in combination w ith 20 mg ethinyloestradiol plus 0.15 mg desogestrel orally for 3 week s. In group P, 13 patients received leuprorelin acetate, following the same schedule as in group A, and placebo. Treatment duration was 6 mo nths. At first-look laparoscopy (postoperatively) group A had an r-AFS score of 23.57 and group P of 24.23, After 6 months of treatment with leuprorelin acetate depot r-AFS scores had dropped to 16.14 in group A and to 6.25 in group P at second-look laparoscopy, achieving statist ical significance in both groups (p < 0.001). Hypooestrogenic adverse drug reactions (e.g. hot flushes, sweating and sleeplessness) were mor e frequently reported in group P, whereas the occurrence of headache w as comparable in both groups, Dysmenorrhoea was significantly reduced in both groups, whereas dyspareunia was only decreased in group P. Var iations in laboratory values were within normal ranges and did not giv e any concern about drug safety. Loss of bone mineral density caused b y the GnRH-a was reduced by the combined oestrogen/progestin add-back therapy. In conclusion: this therapy call lead to a reduction in hypoo estrogenic adverse drug reactions and mostly preserves agonist efficac y with the chance of treatment prolongation.