Uterine Fibroids With MenorrhagiaPhase 2NCT07402369
Phase II Study of CMS-D002 Capsule for Uterine Fibroids With Menorrhagia
A Phase 2 study testing CMS-D002 Capsules 10 mg, CMS-D002 Capsules 25 mg and CMS-D002 Capsules 50 mg in people with Uterine Fibroids With Menorrhagia, run by Shenzhen Kangzhe Biotechnology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Uterine Fibroids With Menorrhagia
- What is being tested?
- CMS-D002 Capsules 10 mg, CMS-D002 Capsules 25 mg and CMS-D002 Capsules 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 19 Feb 2026to 31 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yingfang Zhou, 861083573316, pc54014@163.com
Chao Peng, 861083573316
About this study
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
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.
- Conditions
- Uterine Fibroids With Menorrhagia
- Being tested
- CMS-D002 Capsules 10 mg, CMS-D002 Capsules 25 mg, CMS-D002 Capsules 50 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMS-D002 Capsules 10 mgDrug
CMS-D002 Capsules 10 mg, QD
CMS-D002 Capsules 25 mgDrug
CMS-D002 Capsules 25 mg, QD
CMS-D002 Capsules 50 mgDrug
CMS-D002 Capsules 50 mg, QD
PlaceboDrug
Placebo, QD
| Study group | Role | What they receive |
|---|---|---|
| CMS-D002 Capsules 10 mg | Experimental | CMS-D002 Capsules 10 mg, QD Receives: Drug: CMS-D002 Capsules 10 mg |
| CMS-D002 Capsules 25 mg | Experimental | CMS-D002 Capsules 25 mg, QD Receives: Drug: CMS-D002 Capsules 25 mg |
| CMS-D002 Capsules 50 mg | Experimental | CMS-D002 Capsules 50 mg, QD Receives: Drug: CMS-D002 Capsules 50 mg |
| Placebo | Placebo comparator | Placebo, QD Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline
Measured: 12 weeks
Secondary outcomes (6)
Changes in maximum fibroid volume from baseline
Measured: 12weeks
Changes in uterine volume from baseline
Measured: 12weeks
Percentage of participants without menstrual bleeding or spotting
Measured: 4、8、12 weeks
Changes in hemoglobin concentration from baseline
Measured: 4、8、12 weeks
Changes in uterine fibroid symptoms and quality of life questionnaire (UFS-QoL) scores from baseline
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.
Measured: 12 weeks
Adverse events
Measured: Up to week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start19 Feb 2026
- Primary completion3 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Fibroids With MenorrhagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kangzhe Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402369
- Sponsor's protocol ID
- D002-02-001
- Status last verified
- Mar 2026
- First submitted
- 3 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the privacy and confidentiality of study participants, in accordance with ethical guidelines and regulatory requirements, individual participant data (IPD) will not be shared.