Goserelin acetate (Zoladex) plus endometrial ablation for dysfunctional uterine bleeding: a 3-year follow-up evaluation

Objective: To report the results of a 3-year follow-up evaluation of st tri al comparing goserelin acetate depot injections with sham injections before endometrial ablation for the treatment of dysfunctional uterine bleeding ( DUB). Design: Prospective, randomized, double-blind, parallel-group study. Setting: Thirty-seven centers in 12 countries. Patient(s): Three-hundred and fifty-eight premenopausal women aged over 30 years with DUE. Intervention(s): Goserelin acetate (3.6 mg depot) every 28 days for s weeks , or sham depot every 28 days for s weeks, with endometrial ablation 6 week s +/- 3 days after the first depot injection (i.e., when the endometrium is at its thinnest). The follow-up continued for 3 years. Main Outcome Measure(s): At the 3-year follow-up, bleeding in the previous 3 months and need for surgical intervention were recorded. Result(s): At 3 years, amenorrhea rates were 21% in the goserelin acetate g roup and 14% in the control group (estimated odds ratio, 1.8; 95% CI, 0.98- 3.25; P=.0571). The surgical intervention rate (since the original procedur e) was low and did not differ significantly between groups. For hysterectom y, it was 21% for the goserelin acetate group and 15% for the control group . For repeat ablations, it was 5.6% for the goserelin acetate group and 2.1 % for the control group. Conclusion(s): Prethinning with goserelin acetate before endometrial ablati on resulted in higher long-term amenorrhea rates than ablation without pret hinning. (C) 2001 by American Society for Reproductive Medicine.