Goserelin Acetate as Adjunctive Therapy for Endometrial Ablation in Women with Dysfunctional Uterine Bleeding
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 &plusmn; 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.
Vilos
GA
Department of Obstetrics and Gynecology, St. Joseph's Health Centre, 268 Grosvenor St., London, Onatrio, Canada N6A 4V2.
Donnez
J
Gannon
M
Stampe-Sorensen
S
Klinte
J
Miller
RM