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
To assess the effect and safety of Zoladex (Goserelin acetate) 10.8 mg in patients with uterine fibroids. 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. 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, 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.
Funding
National Key Research and Development Program of China Grant 2022YFC2704102National Natural Science Foundation of China Grant 82071618Natural Science Foundation of Guangdong Province Grant 2023A1515010018Natural Science Foundation of Guangdong Province Grant 2021A1515012615Colin Nova Project of the First Affiliated Hospital of Sun Yat-sen University Grant R08013Science and Technology Project of Guangzhou, China Grant 202201011555Student Innovation Training Program of Sun Yat-sen University Grant 202210698Special Funds for the Cultivation of Guangdong College Students’ Scientific and Technological Innovation Grant pdjh2021b0020