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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
14 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and how the body processes multiple doses of BT-114143 Injection in adult women with abnormal uterine bleeding (AUB). This Phase Ib, randomized, double-blind, placebo-controlled study also explores changes in blood clotting markers and quality of life. The study plans to enroll 39 premenopausal women aged 18 to 50 years with diagnosed abnormal uterine bleeding. Participants are divided into four groups receiving either low, medium, or high doses of BT-114143 Injection or a placebo (normal saline). Each treatment is given twice daily for three consecutive days. The ratio of experimental to control subjects is 10:3 for each dose group. This multiple-dose escalation design helps assess different dose levels of the study drug. During the study, researchers will monitor participants from the first administration until two weeks after the last dose for safety. They will measure changes in menstrual bleeding volume, number of bleeding days, and quality of life using specific questionnaires. Participants will undergo tests to evaluate blood clotting, pregnancy status, and other health indicators. The total participation time includes screening, treatment, and follow-up periods ending December 31, 2025.
CONDITIONS
Brief 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 past 6 months, cycle length 21 to 35 days, period duration up to 14 days
- Diagnosed with abnormal uterine bleeding with menstrual blood loss >80 ml in two consecutive cycles or >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...
- Known endometrial polyps >1.5 cm, endometrial cancer, or atypical hyperplasia
- Ovulatory dysfunctional bleeding requiring hormonal therapy
- Iatrogenic abnormal uterine bleeding
- Bleeding related to coagulation dysfunction including low platelets or prolonged clotting times
- Bleeding caused by cervical or vaginal lesions
- Major surgery within 6 months before screening
- Planned surgical treatments during study period
- Use of certain hormonal or menorrhagia medications within 3 to 6 months prior
- Need for anticoagulants or antiplatelet therapies during study
- Intolerance or contraindication to BT-114143 Injection
- Participation in other clinical trials with treatment within 30 days prior
- Severe diseases or conditions unsuitable for study participation
- History of glaucoma or retinopathy
- Untreated or poorly controlled thyroid dysfunction except mild subclinical hypothyroidism
- History of thrombotic diseases
- Diagnosis of malignant tumors within 5 years except cured basal cell carcinoma
- Abnormal cervical cytology needing treatment
- Abnormal liver, kidney, or blood test results
- Known HIV, hepatitis B, or hepatitis C infection
- Alcohol abuse or drug abuse history within specified timeframes
- Pregnant or lactating, or unprotected sex within 14 days before screening
- Planning pregnancy or unwilling to use contraception during study
- Any condition posing risk to participant or study implementation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive BT-114143 Injection or placebo twice daily for three consecutive days.
Twice daily dosing visits for 3 consecutive days
Duration - 2 weeks
Participants are monitored for safety and changes in menstrual bleeding volume for 2 weeks after treatment ends.
Visits during the 2-week follow-up period for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
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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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