Abnormal Uterine BleedingPhase 1NCT07169214
Evaluation of Safety, Efficacy, and Pharmacokinetics of BT-114143 Injection in Patients With Abnormal Uterine Bleeding
A Phase 1 study testing BT-114143 Injection at low dose, BT-114143 Injection at Medium-dose and BT-114143 Injection at High-dose in people with Abnormal Uterine Bleeding, run by ScinnoHub Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Abnormal Uterine Bleeding
- What is being tested?
- BT-114143 Injection at low dose, BT-114143 Injection at Medium-dose and BT-114143 Injection at High-dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2024to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 subjects, 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 is >80 ml in both cycles; or the blood loss in any one cycle is ≥160 ml;
- 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).
Who cannot join
- 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 upper limit of normal, or PT prolonged by ≥ 3s beyond the upper limit of normal;
- Patients with bleeding caused by cervical or vaginal lesions;
- Patients who have undergone major surgery within 6 months prior to screening;
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- 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 (including but not limited to drugs containing estrogen or progesterone); selective estrogen receptor modulators; hormonal intrauterine devices (LNG-IUS). For long-acting (3-month) gonadotropin-releasing hormone agonists or progesterone preparations, the last administration must be no later than 6 months prior to randomization;
- 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 investigators as unsuitable for participation in the trial;
- 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 content, or 150ml of wine)), or those with a history of drug abuse (such as morphine, tetrahydrocannabinolic acid, methamphetamine, 3,4-methylenedioxymethamphetamine, ketamine) within 1 year before screening, or with mental or neurological diseases that investigators consider may affect participation in the study;
- Pregnant or lactating women, or subjects who had unprotected sex within 14 days before screening;
- Subjects who have plans for pregnancy from the time of signing the informed consent form until 3 months after the last administration, or subjects (or their partners) who are unwilling to take effective contraceptive measures (specific contraceptive measures are shown in Appendix 1);
- Patients with any condition or result that investigators or designated personnel consider may pose a risk to subjects or the implementation of the study;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Qi Yu, 010-69154116, yuqimd@163.com
About this study
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
- Abnormal Uterine Bleeding
- Being tested
- BT-114143 Injection at low dose, BT-114143 Injection at Medium-dose, BT-114143 Injection at High-dose, control group
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT-114143 Injection at low doseDrug
A total of 10 subjects were enrolled. All of them received BT-114143 Injection at low dose. BT-114143 will be administered twice daily for three consecutive days.
BT-114143 Injection at Medium-doseDrug
A total of 10 subjects were enrolled. All of them received BT-114143 Injection at Medium-dose. BT-114143 will be administered twice daily for three consecutive days.
BT-114143 Injection at High-doseDrug
A total of 10 subjects were enrolled. All of them received BT-114143 Injection at High-dose. BT-114143 will be administered twice daily for three consecutive days.
control groupDrug
The ratio of subjects in the experimental group to those in the control group is 10:3, with 3 placebo - treated control subjects corresponding to each dose group. The subjects will receive placebo treatment twice a day for 3 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| low-dose group | Experimental | Subjects received low-dose BT-114143 Injection treatment Receives: Drug: BT-114143 Injection at low dose |
| Medium-dose group | Experimental | Subjects received Medium-dose BT-114143 Injection treatment Receives: Drug: BT-114143 Injection at Medium-dose |
| High-dose Group | Experimental | Subjects received High-dose BT-114143 Injection treatment Receives: Drug: BT-114143 Injection at High-dose |
| control group | Placebo comparator | The subjects receive normal saline treatment. Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety evaluation
The incidence of abnormal laboratory values, clinically significant physical examination findings, vital signs, electrocardiograms (ECGs), and/or treatment-related adverse events/serious adverse events.
Measured: from the first administration to 2 weeks after the last administration
Secondary outcomes (8)
Change of menstrual bleeding volume from baseline
Sanitary products used by subjects are collected regularly, and menstrual blood loss is measured by the alkaline hemoglobin method.
Measured: from signing the informed consent to 2 weeks after the last administration
Percentage change of menstrual bleeding volume from baseline
Sanitary products used by subjects are collected regularly, and menstrual blood loss is measured by the alkaline hemoglobin method.
Measured: from signing the informed consent to 2 weeks after the last administration
The difference in the number of menstrual bleeding days between the post-treatment period and the baseline period in subjects.
Measured: From signing the informed consent to 2 weeks after the last administration
The proportion of subjects with menstrual blood loss ≤ 80 ml after treatment.
Measured: from signing the informed consent to 2 weeks after the last administration
The proportion of subjects with a reduction in menstrual blood loss of ≥50 ml after treatment compared with the baseline
Measured: from signing the informed consent to 2 weeks after the last administration
The proportion of subjects with a reduction in menstrual blood loss of ≥36 ml after treatment compared with the baseline.
Measured: from signing the informed consent to 2 weeks after the last administration
The change in the Menorrhagia Impact Questionnaire (MIQ) score from baseline after treatment in subjects.
Evaluate Menorrhagia Impact Questionnaire (MIQ) score at screening visit and treatment period. The MIQ consists of six individual measures or items. The first 4 items are evaluated by using 4-point (item 1) or 5-point (items 2-4) response scales. No summative scale is derived for item 5 as it serves as a descriptive tool to characterize limitations of specific activities. Item 6 represents a global assessment (impact, degree, and meaningfulness) of the change in MBL when compared to the previous period. Scores correlate with symptom severity; a higher score indicates more severe heavy menstrual bleeding.
Measured: from signing the informed consent to 2 weeks after the last administration
The change in the Menstrual Discomfort Questionnaire (MDQ) score from baseline after treatment in subjects.
A total of 46 related items that reflect eight subscales were included in the MDQ. Each of the eight subscales is composed of an interrelated set of items, and each item is scored on a 5-point Likert scale. The scale ranges from 0 to 184, with higher scores indicating more severe heavy menstrual bleeding.
Measured: from signing the informed consent to 2 weeks after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start30 Oct 2024
- Primary completion23 Sep 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uterine BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ScinnoHub Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169214
- Sponsor's protocol ID
- BT-114143-I-02
- Status last verified
- Dec 2025
- First submitted
- 14 Aug 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety, Efficacy, and Pharmacokinetics of BT-114143 Injection in Patients With Abnormal Uterine Bleeding
- ClinicalTrials.gov ID
- NCT07169214
- Acronym / sponsor ID
- BT-114143-I-02
- Conditions
- Abnormal Uterine Bleeding
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- ScinnoHub Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low-dose group | Experimental | Drug: BT-114143 Injection at low doseSubjects received low-dose BT-114143 Injection treatment |
| Medium-dose group | Experimental | Drug: BT-114143 Injection at Medium-doseSubjects received Medium-dose BT-114143 Injection treatment |
| High-dose Group | Experimental | Drug: BT-114143 Injection at High-doseSubjects received High-dose BT-114143 Injection treatment |
| control group | Placebo comparator | Drug: control groupThe subjects receive normal saline treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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 subjects, 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 is >80 ml in both cycles; or the blood loss in any one cycle is ≥160 ml;
- The pregnancy test result is negative before randomization;
Key exclusion criteria (28 listed)
- 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 upper limit of normal, or PT prolonged by ≥ 3s beyond the upper limit of normal;
- Patients with bleeding caused by cervical or vaginal lesions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BT-114143 Injection at low doseA total of 10 subjects were enrolled. All of them received BT-114143 Injection at low dose. BT-114143 will be administered twice daily for three consecutive days. | Drug | low-dose group |
| BT-114143 Injection at Medium-doseA total of 10 subjects were enrolled. All of them received BT-114143 Injection at Medium-dose. BT-114143 will be administered twice daily for three consecutive days. | Drug | Medium-dose group |
| BT-114143 Injection at High-doseA total of 10 subjects were enrolled. All of them received BT-114143 Injection at High-dose. BT-114143 will be administered twice daily for three consecutive days. | Drug | High-dose Group |
| control groupThe ratio of subjects in the experimental group to those in the control group is 10:3, with 3 placebo - treated control subjects corresponding to each dose group. The subjects will receive placebo treatment twice a day for 3 consecutive days. | Drug | control group |
Primary outcome
safety evaluation
Time frame: from the first administration to 2 weeks after the last administration
The incidence of abnormal laboratory values, clinically significant physical examination findings, vital signs, electrocardiograms (ECGs), and/or treatment-related adverse events/serious adverse events.
8 secondary outcomes
Change of menstrual bleeding volume from baseline
Time frame: from signing the informed consent to 2 weeks after the last administration
Percentage change of menstrual bleeding volume from baseline
Time frame: from signing the informed consent to 2 weeks after the last administration
The difference in the number of menstrual bleeding days between the post-treatment period and the baseline period in subjects.
Time frame: From signing the informed consent to 2 weeks after the last administration
The proportion of subjects with menstrual blood loss ≤ 80 ml after treatment.
Time frame: from signing the informed consent to 2 weeks after the last administration
The proportion of subjects with a reduction in menstrual blood loss of ≥50 ml after treatment compared with the baseline
Time frame: from signing the informed consent to 2 weeks after the last administration
The proportion of subjects with a reduction in menstrual blood loss of ≥36 ml after treatment compared with the baseline.
Time frame: from signing the informed consent to 2 weeks after the last administration
The change in the Menorrhagia Impact Questionnaire (MIQ) score from baseline after treatment in subjects.
Time frame: from signing the informed consent to 2 weeks after the last administration
The change in the Menstrual Discomfort Questionnaire (MDQ) score from baseline after treatment in subjects.
Time frame: from signing the informed consent to 2 weeks after the last administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BT-114143 Injection at low dose, BT-114143 Injection at Medium-dose and BT-114143 Injection at High-dose in people with Abnormal Uterine Bleeding, run by ScinnoHub Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety evaluation (time frame: from the first administration to 2 weeks after the last administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.