Phase II Study of CMS-D002 Capsule for Uterine Fibroids With Menorrhagia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CMS-D002 Capsules 10 mg, CMS-D002 Capsules 25 mg, CMS-D002 Capsules 50 mg, Placebo.
- Who it may be relevant to
- Registry conditions: Uterine Fibroids With Menorrhagia. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase II Clinical Study to Explore the Efficacy and Safety of Different Doses of CMS-D002 Capsule in Participants With Uterine Fibroids Associated With Menorrhagia
Overview
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
- Drug CMS-D002 Capsules 10 mg
CMS-D002 Capsules 10 mg, QD - Drug CMS-D002 Capsules 25 mg
CMS-D002 Capsules 25 mg, QD - Drug CMS-D002 Capsules 50 mg
CMS-D002 Capsules 50 mg, QD - Drug Placebo
Placebo, QD
Primary outcome measures
- Percentage of participants with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline [Time frame: 12 weeks]
Secondary outcome measures (6)
- Changes in maximum fibroid volume from baseline [Time frame: 12weeks]
- Changes in uterine volume from baseline [Time frame: 12weeks]
- Percentage of participants without menstrual bleeding or spotting [Time frame: 4、8、12 weeks]
- Changes in hemoglobin concentration from baseline [Time frame: 4、8、12 weeks]
- Changes in uterine fibroid symptoms and quality of life questionnaire (UFS-QoL) scores from baseline [Time frame: 12 weeks]
- Adverse events [Time frame: Up to week 18]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University First Hospital — Beijing
Identifiers
NCT: NCT07402369 · D002-02-001