Objective: To report the results of a 3-year follow-up evaluation of a trial 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 DUB.
Intervention(s): Goserelin acetate (3.6 mg depot) every 28 days for 8 weeks, or sham depot every 28 days for 8 weeks, with endometrial ablation 6 weeks +/- 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 group 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 procedure) was low and did not differ significantly between groups. For hysterectomy, 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 ablation resulted in higher long-term amenorrhea rates than ablation without prethinning.