Uterine Fibroids With Menorrhagia
Conditions
Brief summary
Objective This study evaluates whether CMS-D002 capsules are effective in treating menorrhagia in participants with uterine fibroids associated with menorrhagia. The primary outcome is the percentage of participants who achieve menstrual blood loss \<80 mL and a reduction of ≥50% from baseline. Study Design This is a placebo-controlled trial. Participants will be randomized to receive either CMS-D002 capsules or a matching placebo for 12 weeks. Participant Responsibilities Take one CMS-D002 capsule or placebo daily for 12 weeks. Complete an electronic patient diary daily throughout the study to record menstrual bleeding and other symptoms.
Interventions
DRUGCMS-D002 Capsules 10 mg
CMS-D002 Capsules 10 mg, QD
DRUGCMS-D002 Capsules 25 mg
CMS-D002 Capsules 25 mg, QD
DRUGCMS-D002 Capsules 50 mg
CMS-D002 Capsules 50 mg, QD
DRUGPlacebo
Placebo, QD
Sponsors
Shenzhen Kangzhe Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 1.Non-menopausal females aged 18-50 years. * 2\. Body Mass Index (BMI) ≥ 18 kg/m². * 3\. Participant was diagnosed with uterine fibroids by ultrasound at the time of screening, and has one or more fibroids with a diameter of at least 2 cm (longest diameter). * 4\. Participant's menstrual cycle was ≥ 21 days and ≤ 35 days for the three consecutive months prior to screening, and the menstrual period was ≤ 14 days. * 5\. Menorrhagia due to uterine fibroids. * 6\. Agrees to use the contraceptive method specified in the protocol throughout the entire study period (from signing the informed consent form to 6 months after administration of the investigational drug).
Exclusion criteria
* 1\. Pregnant or breastfeeding female * 2\. History of childbirth within 6 months prior to screening * 3\. Excessive menstrual bleeding due to other causes or unknown reasons * 4\. Suffering from a severe coagulation disorder (e.g., hemophilia or von Willebrand disease) * 5\. Underwent myomectomy, 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\. Underwent endometrial ablation within one year prior to screening * 7\. Severe infection, severe trauma, or major surgery within the 6 months prior to screening. * 8\. History of malignant tumors within the 5 years prior to screening (excluding cured skin cancer, basal cell carcinoma, and other localized malignant tumors). * 9\. Current or past (within 1 year) history of alcohol or drug abuse (including analgesic abuse). * 10\. Currently participating in other research projects and having used the investigational drug/treatment within 12 weeks prior to administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in maximum fibroid volume from baseline | 12weeks | — |
| Changes in uterine volume from baseline | 12weeks | — |
| Percentage of participants without menstrual bleeding or spotting | 4、8、12 weeks | — |
| Changes in hemoglobin concentration from baseline | 4、8、12 weeks | — |
| Changes in uterine fibroid symptoms and quality of life questionnaire (UFS-QoL) scores from baseline | 12 weeks | Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement. |
| Adverse events | Up to week 18 | — |
Countries
China
Contacts
CONTACTYing Chen
Outcome results
None listed