Actively Recruiting
A Phase II/III Study of Efficacy and Safety of SHR7280 Tablets in Subjects With Menorrhagia With Uterine Fibroids
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2024-01-24
357
Participants Needed
1
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase II:To explore the optimal effective dose of SHR7280 tablets in subjects with menorrhagia with uterine fibroids as a phase III treatment dose. Phase III:To evaluate the efficacy of the selected dose of SHR7280 compared with placebo in reducing menstrual bleeding in subjects with menorrhagic uterine fibroids in phase II studies.
CONDITIONS
Official Title
A Phase II/III Study of Efficacy and Safety of SHR7280 Tablets in Subjects With Menorrhagia With Uterine Fibroids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Female, aged 18 to 49 years (inclusive)
- Single or multiple uterine fibroids confirmed by ultrasound with at least one fibroid 2 cm in diameter
- Heavy menstrual bleeding measured by the alkaline hematin method
- Menstrual cycle length 21-38 days and menstrual period no longer than 14 days within 3 months before screening
- Negative pregnancy test on screening and randomization days
- HPV testing added for subjects with atypical squamous cells on cervical cytology or negative for high-risk HPV
You will not qualify if you...
- Excessive menstrual bleeding and anemia caused by other reasons
- History of depression or clinically significant depression
- History of drug abuse or dependence
- Smoking and alcohol abuse within 3 months before screening
- Pregnancy, delivery, breastfeeding, or miscarriage within 6 months before screening
- Myomectomy within 3 months or uterine artery embolization or HIFU ablation within 6 months before screening
- Endometrial resection within 1 year before screening
- Severe infection, trauma, or major surgery within 6 months before screening
- Major systemic disease, endocrine or metabolic abnormalities
- Past or current thromboembolic disease or risk factors (Phase 2 only)
- History of malignant tumors including ovary, breast, uterus, liver, hypothalamus, pituitary gland, or sex hormone-dependent malignancies
- Diseases affecting drug absorption or metabolism
- Serious mental illness or inability to understand the study
- Live vaccine (except influenza) within 1 month before screening or planned during trial
- Follicle-stimulating hormone (FSH) 25U/L during screening
- Hemoglobin less than 6 g/dL during screening
- Moderate to severe liver impairment during screening
- Endometrial biopsy abnormalities if indicated
- Active pelvic inflammatory disease during screening
- QTcF 450 ms during screening
- Significant infectious disease screening results
- Endometrial biopsy with significant abnormalities within 6 months before enrollment (Phase 2 only)
- Multiple blood transfusions or need for transfusion within specified timeframes
- Use of liver metabolism affecting drugs within 1 month before enrollment
- Participation in other clinical trials within 3 months or still in follow-up or within 5 half-lives of tested drug before screening
- Other investigator-determined reasons inappropriate for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
Z
Zhenyi Zhu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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