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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07402369
- Acronym / sponsor ID
- D002-02-001
- Conditions
- Uterine Fibroids With Menorrhagia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shenzhen Kangzhe Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 3 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CMS-D002 Capsules 10 mg | Experimental | Drug: CMS-D002 Capsules 10 mgCMS-D002 Capsules 10 mg, QD |
| CMS-D002 Capsules 25 mg | Experimental | Drug: CMS-D002 Capsules 25 mgCMS-D002 Capsules 25 mg, QD |
| CMS-D002 Capsules 50 mg | Experimental | Drug: CMS-D002 Capsules 50 mgCMS-D002 Capsules 50 mg, QD |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, QD |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMS-D002 Capsules 10 mgCMS-D002 Capsules 10 mg, QD | Drug | CMS-D002 Capsules 10 mg |
| CMS-D002 Capsules 25 mgCMS-D002 Capsules 25 mg, QD | Drug | CMS-D002 Capsules 25 mg |
| CMS-D002 Capsules 50 mgCMS-D002 Capsules 50 mg, QD | Drug | CMS-D002 Capsules 50 mg |
| PlaceboPlacebo, QD | Drug | Placebo |
Primary outcome
Percentage of participants with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline
Time frame: 12 weeks
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Chen (8615330066563, chenying@cms.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.