Uterine fibroids
Conditions
Interventions
experimental group:one depot of Zoladex 10.8mg
Sponsors
The First Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Informed consent should be provided before any steps related to the study are carried out; 2. Premenopausal women over 18 years old; 3. The patients diagnosed as hysteromyoma by ultrasonography; 4. Patients with anemia (hemoglobin concentration < 11g / dl) or (and) compression related symptoms due to fibroids *; 5. Patients scheduled for surgery; 6. At least one non calcified hysteromyoma with a diameter of more than 3cm was found; * Compression related symptoms include pelvic pain, pelvic discomfort, abdominal distension, frequent urination, dysuria, sexual intercourse pain caused by fibroids compression, and other symptoms assessed by doctors as being caused by fibroids compression.
Exclusion criteria
Exclusion criteria: Patients who met any of the following exclusion criteria were excluded from the study: 1. Pregnancy or lactation or planned or expected pregnancy throughout the study period; 2. Patients receiving sex hormone related treatment in the past month, such as oral contraceptives, estrogen, progesterone, estrogen receptor modulator, progesterone receptor modulator; or GnRH-a treatment in the past 6 months; and; 3. Patients with gynecological tumor or breast cancer or precancerous lesions; 4. Patients with adrenal / pancreatic / ovarian / pituitary tumors; 5. Patients with osteoporosis / osteopenia / metabolic osteopathy; 6. Patients with organ dysfunction were defined as: ·Alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN); ·Serum bilirubin (BR) > 1.5 x ULN; ·Severe renal injury (calculated by Cockcroft Gault formula: creatinine clearance rate < 30 ml / min); ·Platelet < 100 x 10^9 / L; ·Absolute neutrophil count < 1.5 x 10^9 / L 7. Patients requiring immediate blood transfusion or hemoglobin level <= 6 g / dl; 8. Patients with clinical significance of TCT test results in the past 12 months or screening period; 9. Patients who received blood transfusion in the past 8 weeks or donated blood within 2 weeks; 10. Patients with known hemoglobin variant diseases, i.e., sickle cell anemia and thalassemia; 11. Patients with known coagulation disorders; 12. Patients with anemia caused by diseases other than uterine fibroids, such as peptic ulcer or hemorrhoids; 13. Patients who are allergic to GnRH agonists, iron therapy or any component of the study treatment; 14. According to the investigator's judgment, baseline abnormal results that may endanger patient safety or interfere with study evaluation, or any medical or mental illness or laboratory abnormal results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage change in fibroid(s) volume (from baseline to week 12/before surgery);The change in fibroid(s) volume (from baseline to week 12/before surgery); | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in uterine volume (from baseline to week 12/before surgery);The percentage change in uterine volume (from baseline to week 12/before surgery);The change in serum oestradiol (from baseline to week 12/before surgery);The change in follicle stimulating hormone (FSH) (from baseline to week 12/before surgery);The changes in luteinising hormone (LH) (from;The change in hemoglobin concentration (from baseline to week 12/before surgery);The changes in uterine arterial resistance index (RI) (from baseline to week 12/before surgery);The changes in fibroid arterial RI (from baseline to week 12/before surgery); | — |
Countries
China
Contacts
Public ContactShuzhong Yao
The First Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed