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Tests treatment safety and results for Abnormal Uterine Bleeding
Official title Evaluation of Safety, Efficacy, and Pharmacokinetics of BT-114143 Injection in Patients With Abnormal Uterine Bleeding
ClinicalTrials.gov ID: NCT07169214
What this study is testing
What is BT-114143 Injection at low dose?
BT-114143 Injection at low dose is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for abnormal uterine bleeding.
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
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Be able to sign the informed consent form before any study-related procedures are performed, and be willing and able to comply with the study...
- Premenopausal female people, aged 18-50 years, including 18 and 50 years;
- Have regular menstrual cycles in the past 6 months, with a menstrual cycle of ≥21 days and ≤35 days, and a menstrual period duration of ≤14 days;
- Meet the diagnosis of abnormal uterine bleeding and agree to be admitted for treatment. Assessed by the alkaline hemoglobin method, in 2 consecutive...
- The pregnancy test result is negative before randomization;
You likely can't join if
- Patients with known endometrial polyps \> 1.5 cm, endometrial malignancy, or atypical hyperplasia;
- Patients with known or investigator-determined ovulatory dysfunctional abnormal uterine bleeding who require hormonal therapy;
- Patients identified by investigators as having iatrogenic abnormal uterine bleeding;
- Patients with abnormal uterine bleeding related to coagulation dysfunction, including but not limited to those with laboratory test results showing...
- Patients with bleeding caused by cervical or vaginal lesions;
- Patients who have undergone major surgery within 6 months prior to screening;
See the full eligibility criteria
- Be able to sign the informed consent form before any study-related procedures are performed, and be willing and able to comply with the study requirements;
- Premenopausal female people, aged 18-50 years, including 18 and 50 years;
- Have regular menstrual cycles in the past 6 months, with a menstrual cycle of ≥21 days and ≤35 days, and a menstrual period duration of ≤14 days;
- Meet the diagnosis of abnormal uterine bleeding and agree to be admitted for treatment. Assessed by the alkaline hemoglobin method, in 2 consecutive menstrual cycles during the screening period, the menstrual blood loss...
- The pregnancy test result is negative before randomization;
- Those with a body mass index [BMI = weight (kg) / height² (m²)] of 18.5-28.0 kg/m² (including the boundary values).
- Patients with known endometrial polyps \> 1.5 cm, endometrial malignancy, or atypical hyperplasia;
- Patients with known or investigator-determined ovulatory dysfunctional abnormal uterine bleeding who require hormonal therapy;
- Patients identified by investigators as having iatrogenic abnormal uterine bleeding;
- Patients with abnormal uterine bleeding related to coagulation dysfunction, including but not limited to those with laboratory test results showing: platelet count ≤ 100×10⁹/L, or APTT prolonged by ≥ 10s beyond the...
- Patients with bleeding caused by cervical or vaginal lesions;
- Patients who have undergone major surgery within 6 months prior to screening;
- Patients determined by investigators before randomization to require surgical treatments such as total hysterectomy, myomectomy, hysteroscopic treatment, uterine artery embolization, or ablation during the study period;
- Patients who have received the following medications within 3 months prior to randomization: gonadotropin-releasing hormone agonists; sex hormone drugs administered orally, by injection, vaginally, or transdermally...
- Patients who have used danazol, desmopressin, tranexamic acid, aminocaproic acid, or traditional Chinese medicines for the treatment of menorrhagia within 3 months prior to randomization;
- Patients who need to receive anticoagulants (e.g., warfarin, heparin, etc.) or antiplatelet therapies (e.g., clopidogrel, ticagrelor, etc.) during the study period;
- Patients with intolerance or contraindications to BT-114143 Injection;
- Patients who have participated in clinical trials of other investigational drugs, biological agents, or medical devices and received therapeutic interventions within 30 days prior to screening;
- Patients with clinically severe diseases such as known disorders of the circulatory, endocrine, nervous, digestive, respiratory, urinary, hematological, immunological, psychiatric, or metabolic systems, as assessed by...
- Patients with a known history of glaucoma or retinopathy, as assessed by investigators as unsuitable for participation in the trial;
- Untreated or poorly controlled thyroid dysfunction, except for mild subclinical hypothyroidism (i.e., TSH \< 10 mIU/L with normal FT4 and TT4);
- Patients with a known history of thrombotic diseases, including but not limited to pulmonary embolism, deep vein thrombosis, etc.;
- Patients diagnosed with malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin;
- Patients with cervical cytology results indicating a risk of cervical cancer within 1 year prior to the screening period and requiring treatment.
- Patients with one or more of the following abnormal laboratory test results before randomization:
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 1.5 × ULN;
- Total bilirubin \> 1.5 × ULN, except for patients with Gilbert's syndrome;
- eGFR ≤ 60 mL/min/1.73 m² (calculated using the CKD-EPI formula);
- Hemoglobin \< 90 g/L;
- Patients with known infection of human immunodeficiency virus (HIV), or positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus antibody (HCV Ab);
- Alcohol abusers (i.e., consuming more than 14 standard units of alcohol per week within 3 months before screening (1 standard unit contains 14g of alcohol, such as 360ml of beer, 45ml of spirits with 40% alcohol...
- Pregnant or lactating women, or people who had unprotected sex within 14 days before screening;
- people who have plans for pregnancy from the time of signing the informed consent form until 3 months after the last administration, or people (or their partners) who are unwilling to take effective contraceptive...
- Patients with any condition or result that investigators or designated personnel consider may pose a risk to people or the implementation of the study;
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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.