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New treatment option for Uterine Fibroids With Menorrhagia
Official title Phase II Study of CMS-D002 Capsule for Uterine Fibroids With Menorrhagia
ClinicalTrials.gov ID: NCT07402369
What this study is testing
What is CMS-D002 Capsules 10 mg?
CMS-D002 Capsules 10 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for uterine fibroids with menorrhagia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- 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...
- 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...
- 5\. Menorrhagia due to uterine fibroids.
You likely can't join if
- 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...
- 6\. Underwent endometrial ablation within one year prior to screening
See the full eligibility 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.