ABSTRACT
The multinational, multicenter, prospective, double-blind study compared randomized 358 premenopausal women with regular cycles to receive two injections 1 month apart of goserelin acetate depot or sham depot before endometrial ablation. Injections were started to permit surgery (resection ± rollerball) 6 weeks later on day 7 of the cycle when the endometrium would be at its thinnest for the sham group, and allowing down-regulation to continue after surgery. End points were endometrial thickness at surgery, change in blood loss score, amenorrhea, severe hypomenorrhea (score <10), ease and duration of surgery, fluid absorption, change in pain score and endometrial histology. Intent-to-treat analysis was performed. Significantly more women receiving goserelin experienced amenorrhea (40%) than those receiving sham (26%, p = 0.004). The change in blood loss score was significantly reduced from baseline but not different between the groups. The combination of amenorrhea and severe hypomenorrhea favored the goserelin group (p = 0.059). Mean endometrial thickness for goserelin was 1.6 mm and for sham 3.4 mm (p = 0.0001). The majority of women given goserelin had atrophic glands and stroma. Surgery in these patients was significantly shorter (22%, p = 0.0001) and easier than for those treated with sham (p = 0.0001). Operative complications were similar between the groups, with a small but significant difference in favor of goserelin for less fluid absorption (p = 0.04). Pain scores were reduced in both groups. Patient satisfaction was very high in both groups (>92%) with a very low reintervention rate (2.8% for both groups). Overall menstrual loss was reduced. Despite timing the surgery to favor the sham group, the goserelin-treated women had significantly more amenorrhea and significant thinner endometria than seen in the immediate postmenstrual phase, and this resulted in significantly shorter and easier surgery.
