Uterine fibroids with menorrhagia
Conditions
Interventions
Group A:CMS-D002 Capsules 10 mg, QD
Group B:CMS-D002 Capsules 25 mg, QD
Group C:CMS-D002 Capsules 50 mg, QD
Group D:Placebo, QD
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Those who can understand and abide by the research procedures and methods of this trial, voluntarily participate in this trial and sign the informed consent form. 2. Must be a non-menopausal woman aged 18-50 years (including the threshold value); 3. Body mass index (BMI) of participants>=18 kg/m^2; 4. Participants were diagnosed with uterine fibroids by ultrasound at the time of screening and had one or more fibroids with a diameter of at least 2 cm (longest diameter) 5. Participants had 3 consecutive menstrual cycles>=21 days and <=35 days before screening, and menstrual periods<=14 days. 6. Menorrhagia caused by uterine fibroids. 7.Agree to use AHM special sanitary products provided by the sponsor as required. 8. During the whole study period (from the signing of the informed consent form to 6 months after the administration of the investigational product), consent was given to the use of the contraceptive method specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. History of delivery within 6 months before screening; 3. Excessive menstrual bleeding caused by other reasons or unknown reasons; 4. severe coagulation disorder (E. G., hemophilia or von Willebrand disease); 5. Myomectomy or endometrial ablation, uterine artery embolization, or magnetic resonance guided focused ultrasound (MRgFUS)/high intensity focused ultrasound (HIFUS) ablation within 6 months prior to screening 6. Endometrial resection within one year before screening; 7. Cervical pathology with any of the following within 6 months prior to screening or during screening: high-grade cervical tumors, atypical glandular cells, atypical endocervical cells, and atypical squamous cells tend to be high-grade. Human papillomavirus (HPV) testing was available as an adjunct test for participants with atypical squamous cells of uncertain significance (ASCUS), and participants with a diagnosis of ASCUS who were negative for high-risk HPV were eligible for inclusion in the study; 8. Allergic to GnRH antagonists, experimental drugs and excipients, iron or sanitary products provided by the sponsor; 9. Known history of failure to treat uterine fibroids with gonadotropin-releasing hormone (GnRH) agonists or antagonists; 10. Use of contraceptive injections prior to screening (contraindicated 3 months prior to screening with medroxyprogesterone acetate, contraindicated 1 month prior to screening with other injections), use of contraceptive patches 1 month prior to screening; other contraceptive conditions were judged by the investigator; 11. History of osteoporosis before and during screening, known osteoporosis or other metabolic bone diseases, or bone mineral density Z value =25 IU/L; 15. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamine transaminase (GGT) >=2 times of the upper limit of normal or total bilirubin >=1.5 times of the upper limit of normal during screening; 16. Patients with positive HIV antibody, hepatitis B virus surface antigen and hepatitis C virus antibody during the screening period; patients with positive Treponema pallidum antibody are excluded if the additional rapid plasma reagin circle card test (RPR) or toluidine red unheated serum test (TRUST) is negative; 17. QT interval (QTcF) > 470 ms corrected by Fridericia formula during screening; 18. Two or more blood transfusions within 6 months before screening, or blood transfusion treatment within 2 months before randomization, or any condition requiring immediate blood transfusion; 19. Severe pelvic inflammatory disease during screening period; 20. Clinically significant systemic disease within 6 months prior to screening or during screening; 21. Patients with severe infection, severe trauma or major surgical operation within 6 months before screening 22. Patients with a history of malignant tumors within 5 years before screening (except for local malignant tumors such as skin cancer and basal cell carcinoma that have been cured) 23. Current or past (wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with reduced menstrual bleeding at 12 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum uterine fibroid volume reduction at 12 weeks of treatment;Uterine volume reduction rate at 12 weeks of treatment;Percent of participants without menstrual bleeding at week 12 of treatment;Absolute change from baseline and percentage change from baseline in Hb at Week 12;Amount of bleeding in the first 28 days at week 4;Uterine fibroid symptom severity and quality of life scale (UFS QoL) score at the 12th week of treatment;Amount of bleeding in the first 28 days at week 8;Amount of bleeding in the first 28 days at week 12; | — |
Countries
China
Contacts
Public ContactZhou Yingfang;Peng Chao
Peking University First Hospital
Outcome results
None listed