Multicenter, prospective, single-arm clinical study to investigate the efficacy and safety of Zoladex (Goserelin acetate) 10.8 mg prior to surgery in Chinese premenopausal women with symptomatic uterine fibroids

Objectives To assess the effect and safety of Zoladex (Goserelin acetate) 10.8 mg in patients with uterine fibroids.Methods Fifty-three patients received Goserelin acetate 10.8 mg once and surgery was conducted at 12 weeks ± 7 days after drug injection. All assessments form baseline to week12/before surgery were carried out: fibroids volume, uterine volume, serum hormone (E2, FSH, LH), hemoglobin concentration, uterine arterial resistance index (UA-RI), fibroid arterial RI (FA-RI) and improvements of symptoms (Uterine Fibroid Symptom and Quality of Life (UFS-QOL) and Health-Related Quality of Life (HRQL) scores). Adverse events (AEs) were recorded to evaluate the safety.Results After 12 weeks of treatment, the volume of uterine fibroids was significantly smaller than before (249.19 ± 297.04 vs. 195.77 ± 418.27 cm3, p