Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:01 AM
Study NCT ID:
NCT07402369
Status:
RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of CMS-D002 Capsule for Uterine Fibroids With Menorrhagia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in maximum fibroid volume from baseline', 'timeFrame': '12weeks'}, {'measure': 'Changes in uterine volume from baseline', 'timeFrame': '12weeks'}, {'measure': 'Percentage of participants without menstrual bleeding or spotting', 'timeFrame': '4、8、12 weeks'}, {'measure': 'Changes in hemoglobin concentration from baseline', 'timeFrame': '4、8、12 weeks'}, {'measure': 'Changes in uterine fibroid symptoms and quality of life questionnaire (UFS-QoL) scores from baseline', 'timeFrame': '12 weeks', 'description': '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.'}, {'measure': 'Adverse events', 'timeFrame': 'Up to week 18'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uterine Fibroids With Menorrhagia']}, 'descriptionModule': {'briefSummary': '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.\n\nStudy Design This is a placebo-controlled trial. Participants will be randomized to receive either CMS-D002 capsules or a matching placebo for 12 weeks.\n\nParticipant 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1.Non-menopausal females aged 18-50 years.\n* 2\\. Body Mass Index (BMI) ≥ 18 kg/m².\n* 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).\n* 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.\n* 5\\. Menorrhagia due to uterine fibroids.\n* 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).\n\nExclusion Criteria:\n\n* 1\\. Pregnant or breastfeeding female\n* 2\\. History of childbirth within 6 months prior to screening\n* 3\\. Excessive menstrual bleeding due to other causes or unknown reasons\n* 4\\. Suffering from a severe coagulation disorder (e.g., hemophilia or von Willebrand disease)\n* 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\n* 6\\. Underwent endometrial ablation within one year prior to screening\n* 7\\. Severe infection, severe trauma, or major surgery within the 6 months prior to screening.\n* 8\\. History of malignant tumors within the 5 years prior to screening (excluding cured skin cancer, basal cell carcinoma, and other localized malignant tumors).\n* 9\\. Current or past (within 1 year) history of alcohol or drug abuse (including analgesic abuse).\n* 10\\. Currently participating in other research projects and having used the investigational drug/treatment within 12 weeks prior to administration."}, 'identificationModule': {'nctId': 'NCT07402369', 'briefTitle': 'Phase II Study of CMS-D002 Capsule for Uterine Fibroids With Menorrhagia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenzhen Kangzhe Biotechnology Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'D002-02-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CMS-D002 Capsules 10 mg', 'description': 'CMS-D002 Capsules 10 mg, QD', 'interventionNames': ['Drug: CMS-D002 Capsules 10 mg']}, {'type': 'EXPERIMENTAL', 'label': 'CMS-D002 Capsules 25 mg', 'description': 'CMS-D002 Capsules 25 mg, QD', 'interventionNames': ['Drug: CMS-D002 Capsules 25 mg']}, {'type': 'EXPERIMENTAL', 'label': 'CMS-D002 Capsules 50 mg', 'description': 'CMS-D002 Capsules 50 mg, QD', 'interventionNames': ['Drug: CMS-D002 Capsules 50 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, QD', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CMS-D002 Capsules 10 mg', 'type': 'DRUG', 'description': 'CMS-D002 Capsules 10 mg, QD', 'armGroupLabels': ['CMS-D002 Capsules 10 mg']}, {'name': 'CMS-D002 Capsules 25 mg', 'type': 'DRUG', 'description': 'CMS-D002 Capsules 25 mg, QD', 'armGroupLabels': ['CMS-D002 Capsules 25 mg']}, {'name': 'CMS-D002 Capsules 50 mg', 'type': 'DRUG', 'description': 'CMS-D002 Capsules 50 mg, QD', 'armGroupLabels': ['CMS-D002 Capsules 50 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, QD', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingfang Zhou', 'role': 'CONTACT', 'email': 'pc54014@163.com', 'phone': '861083573316'}, {'name': 'Chao Peng', 'role': 'CONTACT', 'phone': '861083573316'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ying Chen', 'role': 'CONTACT', 'email': 'chenying@cms.net.cn', 'phone': '8615330066563'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen Kangzhe Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}