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Evaluation of Safety, Efficacy, and Pharmacokinetics of BT-114143 Injection in Patients With Abnormal Uterine Bleeding
Led by ScinnoHub Pharmaceutical Co., Ltd. · Updated on 2025-12-15
39
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, double-blind, placebo-controlled, multiple-dose escalation, Phase Ib clinical study conducted in patients with abnormal uterine bleeding (e.g., AUB). It aims to evaluate the safety, efficacy, pharmacokinetic characteristics of multiple administrations of BT-114143 Injection at different doses, as well as to explore changes in coagulation-related biomarkers and quality of life. It is planned to enroll 39 adult patients with abnormal uterine bleeding.
CONDITIONS
Official Title
Evaluation of Safety, Efficacy, and Pharmacokinetics of BT-114143 Injection in Patients With Abnormal Uterine Bleeding
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to sign informed consent and comply with study requirements
- Premenopausal female aged 18 to 50 years
- Regular menstrual cycles for the past 6 months, lasting 21 to 35 days, with menstrual periods not exceeding 14 days
- Diagnosed with abnormal uterine bleeding, with menstrual blood loss over 80 ml in two consecutive cycles or over 160 ml in one cycle
- Negative pregnancy test before randomization
- Body mass index between 18.5 and 28.0 kg/m²
You will not qualify if you...
- Presence of endometrial polyps larger than 1.5 cm, endometrial cancer, or atypical hyperplasia
- Ovulatory dysfunctional abnormal uterine bleeding requiring hormonal therapy
- Iatrogenic abnormal uterine bleeding
- Bleeding related to coagulation disorders, including low platelet count or prolonged clotting times
- Bleeding caused by cervical or vaginal lesions
- Major surgery within 6 months before screening
- Requirement for surgical treatments like hysterectomy or myomectomy during the study
- Use of certain hormonal or related medications within 3 to 6 months before randomization
- Use of specific menorrhagia treatments within 3 months before randomization
- Need for anticoagulant or antiplatelet therapy during the study
- Intolerance or contraindications to BT-114143 Injection
- Participation in other clinical trials with therapeutic interventions within 30 days before screening
- Severe diseases affecting major body systems deemed unsuitable for participation
- History of glaucoma or retinopathy deemed unsuitable
- Untreated or poorly controlled thyroid dysfunction except mild subclinical hypothyroidism
- History of thrombotic diseases like pulmonary embolism or deep vein thrombosis
- Diagnosis of malignant tumors within 5 years except cured basal cell carcinoma
- Cervical cytology indicating cancer risk within 1 year prior to screening
- Abnormal liver function, kidney function, or low hemoglobin levels
- Known HIV infection or positive hepatitis B or C markers
- Alcohol abuse or recent drug abuse history or mental/neurological diseases affecting participation
- Pregnant or lactating women or recent unprotected sex
- Plans for pregnancy or unwillingness to use effective contraception from consent until 3 months after last dose
- Any condition posing risk to participant or study implementation as judged by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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