Adenomyosis
Conditions
Interventions
Group A:A 10.8 mg goserelin acetate sustained-release implant is subcutaneously injected every 12 weeks, and a total of 2 injections are given according to the patients condition
Group B:A 3.6 mg goserelin acetate sustained-release implant is subcutaneously injected every 4 weeks, and a total of 6 injections are given according to the patients condition
Group C:One injection of 10.8mg goserelin acetate sustained-release implant, followed by a total of three injections of 3.6mg goserelin acetate sustained-release implant.
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Female, aged 18 years or older, premenopausal, who agrees to receive goserelin (Zoladex™) treatment and signs the informed consent form; 2. Patients with adenomyosis confirmed by outpatient or inpatient auxiliary examinations such as transvaginal ultrasound and/or magnetic resonance imaging (MRI), with exclusion of tumor factors, who request temporary avoidance of surgery, or those with pathologically diagnosed adenomyosis after surgery; 3. Presence of dysmenorrhea with or without menorrhagia; 4. No history of other hormone-based drug treatments for adenomyosis within 3 months prior to initiating the current medication; 5. Normal or clinically insignificant cervical cytology results (must be obtained within 6 months before the screening period).
Exclusion criteria
Exclusion criteria: 1.Symptoms such as pelvic pain or vaginal bleeding caused by unknown reasons or non-adenomyosis factors; 2.Patients receiving other hormone-based drug treatments for adenomyosis; those who have used GnRH-a therapy within 3 months; patients with a levonorgestrel-releasing intrauterine system (LNG-IUS) in place; 3.Patients currently using other drugs that have interactions with the study drug and cannot discontinue their use; 4.Patients with severe heart, liver, or kidney diseases, or adrenal cortical insufficiency; those with drug allergies or allergic diathesis; 5.Patients who have participated in other clinical trials within 3 months; and other factors deemed inappropriate for trial participation by researchers; 6.Pregnant or lactating patients; patients with fertility requirements; patients with poor ovarian reserve function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uterus size;Menstrual days;Degree of menstrual pain;Bleeding volume;Follicle-Stimulating Hormone;Luteinizing Hormone;Estradiol;anti-Müllerian hormone;Time of menstrual resumption;Lesion size;Progesterone; | — |
Secondary
| Measure | Time frame |
|---|---|
| Carbohydrate antigen-125;Liver function;Kidney function;Adverse Reaction;Complete Blood Count;Bone density; | — |
Countries
China
Contacts
Public ContactHan Liping
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed