Clinical Efficacy And Safety Of Goserelin Acetate 10.8mg In Premenopausal Patients With Symptomatic Adenomyosis

BackgroundAdenomyosis is a common benign gynecological disease that refers to lesions caused by invasion of the endometrium(including glands and stroma)into the myometrium and diffuse or focal growth within the myometrium.Adenomyosis usually occurs in women of childbearing age,but its exact etiology and occurrence have not yet been determined.The main clinical symptoms of adenomyosis include dysmenorrhea,hypermenorrhea.and subfertility,which can seriously impact the physical and mental health of female patients.Gonadotropin-releasing hormone agonists(GnRH-a)is one of the most effective drugs in the clinical treatment of adenomyosis,providing rapid and effective relief of dysmenorrhea,treatment of menorrhagia,and reduction of uterine volume.The most commonly used GnRH-a in the clinical treatment of uterine adenomyosis is the monthly dosage form,injected every 28 days for 3-6 months or longer,which greatly increases the number of outpatient visits and medical expenses for patients.Goserelin Acetate Sustained-Release Depot(Zoladex)is a synthetic decapeptide analogue of luteinizing hormone-releasing hormone(LHRH);clinical therapy formulations include subcutaneous goserelin with sustained-release over 1(3.6 mg)or 3(10.8 mg)months.The main clinical use for the treatment of adenomyosis is now the monthly(3.6 mg)dosage form.Goserelin 10.8 mg is a trimonthly dosage form,originally mainly used for treating prostate cancer and is now gradually used for treating breast cancer and several benign gynecological diseases.Still,there are currently no valid clinical studies using goserelin 10.8 mg to treat adenomyosis.This study was conducted to compare the clinical efficacy and safety of trimonthly administration of goserelin 10.8 mg and monthly administration of goserelin 3.6 mg in the treatment of premenopausal patients with symptomatic adenomyosis,in order to provide a more convenient treatment option for patients with adenomyosis.ObjectiveTo compare the clinical efficacy and safety of goserelin 10.8 mg administered trimonthly with goserelin 3.6 mg administered monthly in premenopausal females with symptomatic adenomyosis.Materials and MethodsA total of 139 premenopausal female patients with adenomyosis presenting to the gynecology outpatient clinic with complaints of dysmenorrhea and/or menorrhagia were included in the study.The patients were alternately assigned to one of the two groups according to the enrollment order.The first group(70 patients)received a single subcutaneous injection of goserelin 10.8 mg,and the second group(69 patients)received a monthly(every 4 weeks)subcutaneous injection of goserelin 3.6 mg for 3 months.General demographics and disease characteristics of the patients were collected by questionnaire at trial enrollment,and patients were followed up for 12 weeks.Numerical rating scale(NRS)was used to assess the degree of dysmenorrhea,gynecological ultrasound was used to assess the volume of the patients’ uterus,hemoglobin(HGB)level was primarily used to assess the condition of hypermenorrhea.and the change of carbohydrate antigen 125(CA 125)was monitored before and after treatment.Adverse events and related scores reported by the patients throughout the treatment were recorded at follow-up.ResultsUltimately,a total of 130 patients in both groups completed the study,68 and 62 in the goserelin 10.8 mg(70 patients)and 3.6 mg(69 patients)groups,respectively.After 12 weeks of treatment,the dysmenorrhea(NRS)scores,uterine volume,and CA 125 levels were significantly decreased in both groups,HGB levels were significantly increased,and there was no significant difference between the two groups(P=0.62,P=0.32,P=0.27,P=0.05,respectively).The sum of the adverse event scores was slightly higher in the goserelin 3.6 mg group than in the 10.8 mg group(9.73±5.28 vs.7.62±4.98,P=0.02).ConclusionTrimonthly administration of goserelin 10.8 mg was equivalent to monthly dosing of goserelin 3.6 mg in clinical efficacy.It was non-inferior to the monthly dosing regimen regarding safety and tolerability.Hence,it can be a more cost-effective and convenient alternative treatment option in premenopausal patients with symptomatic adenomyosis.