menorrhagia associated with uterine fibroids
Conditions
Interventions
trial group:Oral relugolix
control group:Oral placebo
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.Subjects who can understand and comply with the study procedures and methods of this trial, voluntarily participate in the trial, and sign the informed consent form; 2.Premenopausal females aged 18 to 50 years (inclusive) on the date of signing the informed consent form; 3.Uterine fibroids confirmed by transvaginal/rectal gynecological ultrasound during screening, meeting at least one of the following criteria:(1).Subserosal sessile fibroids, submucosal sessile fibroids, or intramural fibroids with the maximum diameter >=2 cm;(2).Multiple small fibroids with uterine volume >=130 cm³; 4.Menorrhagia caused by uterine fibroids, as measured by the alkaline heme method during screening:Menstrual blood volume >=80 mL in two measurements,Or >=160 mL in one measurement,Or >=80 mL in one measurement with anemia (Hb <110 g/L); 5.Menstrual cycle of 21 to 38 days (inclusive, calculated from the start of one menstruation to the start of the next) and menstrual period of 3 to 14 days (inclusive) within 3 months before screening; 6.Willing to use effective non-hormonal contraceptive measures from the signing of the informed consent form to 35 days after the last drug administration, and not donate oocytes; willing to use effective hormonal or non-hormonal contraceptive measures for 6 months after the end of the 35-day period following the last drug administration.
Exclusion criteria
Exclusion criteria: 1.Known allergy to the investigational drug and its excipients, or history of allergy to GnRH agonists/antagonists; 2.Previous failure in treating uterine fibroids with GnRH agonists or antagonists; 3.Presence of other diseases during the screening period that may cause menorrhagia, such as: adenomyosis confirmed by B-ultrasound (e.g., adenomyoma, diffuse adenomyosis), endometrial or cervical polyps >=2.0 cm, ovarian cysts >4.0 cm, etc; 4.There are circumstances where a qualified DXA scan of the lumbar spine (L1-L4), total hip, or femoral neck cannot be performed, such as: excessive body weight, history of bilateral hip arthroplasty, or history of spinal perfusion in the lumbar spine, etc; 5.During the screening period, DXA results of the lumbar spine (L1-L4), total hip, or femoral neck show a Z-score 14 days) within 3 months before screening, except for local use (e.g., topical, inhaled, etc.); 9.History of malignant tumors within 5 years before screening (excluding cured localized malignancies such as skin cancer and basal cell carcinoma); 10.History of drug abuse, alcohol abuse, or drug dependence within 2 years before screening; 11.Underwent or planned to undergo myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, uterine artery embolization, magnetic resonance-guided focused ultrasound, endometrial resection within 6 months before screening; or planned to undergo hysterectomy or bilateral oophorectomy during the study; 12.Presence of an in-situ copper intrauterine device (IUD)/progestin-releasing IUD, subdermal contraceptive implant, or vaginal contraceptive ring during screening. Screening is allowed if the subject can remove the IUD/subdermal implant/vaginal ring at least 1 month before screening; 13.History of or current thromboembolic diseases (e.g., pulmonary embolism, deep vein thrombosis, acute coronary syndrome, stroke, etc.); 14.Breast ultrasound results during screening classified as other than BI-RADS (Breast Imaging Reporting and Data System) categories 1-3; 15.Use of any prohibited medications specified in the protocol at screening or expected during the study (see Attachment 2 for details, including appropriate exclusion windows for these medications); 16.Current or past medical history of the following diseases: (1).Unexplained genital tract bleeding or excessive menstrual bleeding from other causes during screening;(2).Active pelvic inflammatory disease during screening;(3).Digestive system diseases affecting drug absorption during screening, such as active gastric or duodenal ulcer, Crohn's disease, acute pancreatitis, etc;(4).Hematological diseases causing anemia during screening, such as thalassemia, sickle cell anemia, folate deficiency (excluding iron-deficiency anemia);(5).Known coagulation disorders during screening, such as h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Menstrual blood loss; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in hemoglobin;Numeric Rating Scale score;Change in uterine fibroid volume; | — |
Countries
China
Contacts
Public ContactYingfang Zhou
Peking University First Hospital
Outcome results
None listed