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.

Abstract

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 < 0.0001). The volume of the uterus was also smaller than before (372.02 vs. 263.58 cm3, p < 0.0001). Serum levels of E2, FSH, and LH showed significant decreasing trend (61.13 pmol/L, 5.23 IU/L and 4.75 IU/L respectively, p < 0.0001) and hemoglobin levels were increased significantly (108.30 ± 26.28 VS. 134.90 ± 9.21g/L, p < 0.0001). Left and right UA-RI showed slight increase of 0.04 and 0.02 respectively from baseline without significance. Mean FA-RI showed slight decrease of 0.03 from baseline (p = 0.22). Patient symptoms were alleviated after treatment. In addition, AEs occurred in 81.1% of enrolled patients and all AEs were well tolerably.

Conclusions: Goserelin acetate 10.8 mg pretreatment can effectively reduce the volume of uterine fibroids and uterus, lower estrogen levels and improve anemia symptoms. It could also improve the quality of life of patients, showing good safety and tolerance. This pretreatment was effective, safe, and generally well tolerated.