Uterine Fibroids With MenorrhagiaPhase 2/3NCT05442827
A Phase II/III Study of Efficacy and Safety of SHR7280 Tablets in Subjects With Menorrhagia With Uterine Fibroids
A Phase 2/3 study testing SHR7280 tablets in people with Uterine Fibroids With Menorrhagia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Uterine Fibroids With Menorrhagia
- What is being tested?
- SHR7280 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 357 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2022to 1 Jun 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The informed consent has been signed and dated;
- Non-menopausal women between the ages of 18 and 49 (including 18 and 49);
- Single or multiple uterine fibroids were confirmed by ultrasound examination during screening, and the maximum diameter of at least one fibroid was ≥2 cm;
- Heavy menstrual bleeding measured by the alkaline hematin method during screening;
- 3 months before screening, the subject's menstrual cycle is 21-38 days, and the period is no more than 14 days;
- The pregnancy test was negative on the day of screening visit and randomization;
- Human papillomavirus (HPV) testing should be added for subjects who have cervical cytology at the time of screening visit and whose TCT results are atypical squamous cells (ASC-US) of uncertain significance, or who test negative for high-risk HPV.
Who cannot join
- Excessive menstrual bleeding and anemia caused by other reasons;
- A history of depression or clinically significant depression;
- Have a history of drug abuse, drug dependence;
- History of smoking and alcohol abuse within 3 months prior to screening;
- A history of delivery, breastfeeding and miscarriage within 6 months prior to screening;
- Patients who received myomectomy within 3 months before screening, and patients who received uterine artery embolization, or high intensity focused ultrasound (HIFU) ablation within 6 months before screening;
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- Patients who underwent endometrial resection within 1 year prior to screening;
- Patients with severe infection (one organ or whole body infection caused by pathogenic microorganism, and failure or death of the organ or multiple organs caused by infection), severe trauma (ISS ≥16 points) or major surgery (grade III/IV surgery in Surgical Classification Catalogue) within 6 months prior to screening;
- Previous clinical major systemic disease, endocrine or metabolic abnormalities;
- Having past or current thromboembolic disease or having a risk factor for thromboembolic disease (stage 2 only);
- Previous history of malignant tumors such as ovary, breast, uterus, liver, hypothalamus and pituitary gland;Known or suspected sex hormone-dependent malignancies;
- Any pre-existing disease or symptom (e.g., chronic intestinal disease, Crohn's disease, ulcerative colitis) that may affect systemic functioning of the body and may affect absorption, excessive accumulation, metabolism, or change the excretion pattern of the test drug;
- Persons with prior known serious mental illness or inability to understand the purpose, methods, etc. of the clinical trial, and who did not follow the study procedures;
- Live (attenuated) vaccine (other than influenza vaccine) received within 1 month prior to screening or planned during the trial;
- Other reasons that the investigator considered inappropriate for participation in the study.
- Follicle-stimulating hormone (FSH) ≥25U/L during screening;
- Hb < 6 g/dL during screening;
- Moderate to severe liver impairment during screening, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin (unless Gilbert's diagnosis is known) ≥2.0 times the upper limit of the reference range;
- During screening, endometrial biopsy should be performed if endometrial thickness > 18 mm is indicated by gynecological ultrasound or if the investigator deems it necessary. Endometrial histological abnormalities indicated by endometrial biopsy should be performed (only in the first stage).
- Active pelvic inflammatory disease (PID) during screening;
- QTcF≥450ms during screening;
- Infectious disease screening resultshave clinical significance;
- 6 months before enrollment, endometrial biopsy revealed significant endometrial histological abnormalities;If the subject has no sexual life history or the investigator determines that it is not necessary, the subject may be exempted (stage 2 only);
- Two or more blood transfusions within 9 months prior to enrollment, or requiring transfusion therapy within 2 months prior to enrollment, or having any condition requiring immediate transfusion;
- 1 month before admission, she used any drugs that inhibited or induced liver metabolism of drugs (liver drug enzyme inhibitors such as chloramphenicol, allopurinol,ketoconazole, fluoroquinolones, etc., and liver drug enzyme inducers such as carbamazepine, dexamethasone, phenobarbital, phenytoin sodium, rifamequine);
- Participants in and enrolled in clinical trials of any drug or medical device within 3 months prior to enrollment, or who were still in the follow-up period of a clinical study or within 5 half-lives of the tested drug prior to screening, whichever is longer.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yingfang Zhou
Chao Peng
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Phase II/III Clinical Study to Explore the Optimal Therapeutic Dose of SHR7280 Tablets and the Efficacy and Safety of SHR7280 Tablets in Subjects With Menorrhagia for Uterine Fibroids
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
- Uterine Fibroids With Menorrhagia
- Being tested
- SHR7280 tablets, PlaceboSHR7280 tablets blank preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR7280 tabletsDrug
SHR7280 tablets 300mg for 12 weeks
SHR7280 tabletsDrug
SHR7280 tablets 400mg for 12 weeks
PlaceboSHR7280 tablets blank preparationDrug
Placebo group: SHR7280 tablets blank preparation for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: SHR7280 tablets | Experimental | Not described Receives: Drug: SHR7280 tablets |
| Treatment group B:SHR7280 tablets | Experimental | Not described Receives: Drug: SHR7280 tablets |
| Treatment group C:Intervention: Drug: PlaceboSHR7280 tablets blank preparation | Placebo comparator | Not described Receives: Drug: PlaceboSHR7280 tablets blank preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase one：Percentage of subjects with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline
Measured: After treatment at week 12
Phase two：Percentage of subjects with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline
Measured: After treatment at week 24
Secondary outcomes (26)
Percentage of subjects with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline（Phase one）
Measured: The treatment ended at week 4 and 8
percentage of subjects without menstrual bleeding or spotting （Phase one）
Measured: The treatment ended at week 4, 8 and 12
Changes in hemoglobin concentration from baseline（Phase one）
Measured: The treatment ended at week 4, 8 and 12
Changes in uterine volume and maximum fibroid volume from baseline（Phase one）
Measured: The treatment ended at week 8 and 12
patient global impression of change scale evaluation，The minimum is 1, the maximum is 7, and higher scores mean worse results（Phase one）
Measured: The treatment ended at week 12
Changes in uterine fibroid symptoms from baseline（Phase one）
Measured: The treatment ended at week 12
Changes in health related Quality of Life Questionnaire (UFS-QOL) scores from baseline，The minimum is 37 and the maximum is 185, with higher scores indicating worse results（Phase one）
Measured: The treatment ended at week 12
Number of Participants with Adverse events（Phase one）
Measured: Stage ⅱ ended, about 30 weeks
The interval between stopping the medication and resuming menstruation（Phase one）
Measured: Stage ⅱ ended, about 30 weeks
The amount of menstrual bleeding when the medication was stopped until menstruation resumed（Phase one）
Measured: Stage ⅱ ended, about 30 weeks
Number of days of menstruation from the time of discontinuation of the medication to the time of resumption of menstruation(Phase one)
Measured: Stage ⅱ ended, about 30 weeks
SHR7280 concentration in plasma(Phase one)
Measured: Before and at week 4, 8 and 12 after administration
Serum concentrations of estradiol, luteinizing hormone, follicle stimulating hormone and progesterone(Phase one)
Measured: Before and at week 4, 8 and 12 after administration
Percentage of subjects with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline（Phase two）
Measured: At the end of weeks 4,8,12,16,20,28,32,36,40,44,48,52
Changes in menstrual bleeding from baseline were assessed using the Alkaline hematin method (AH)（Phase two）
Measured: At the end of weeks 4,8,12,16,20,24,28,32,36,40,44,48,52
percentage of subjects without menstrual bleeding or spotting (Phase two)
Measured: Weeks 4,8,12,16,20,24,28,32,36,40,44,48,52
change in Hb concentration from baseline (Phase two）
Measured: The treatment ended at 4, 8, 12, 16, 20, 24, 36, 44, 52 weeks
Changes in uterine volume and maximum fibroid volume from baseline(Phase two)
Measured: The treatment ended at weeks 12, 24, and 52
patient global impression of change scale evaluation，The minimum is 1, the maximum is 7, and higher scores mean worse results(Phase two)
Measured: The treatment ended at weeks 12, 24, and 52
Changes in health related Quality of Life Questionnaire (UFS-QOL) scores from baseline，The minimum is 37 and the maximum is 185, with higher scores indicating worse results(Phase two)
Measured: The treatment ended at weeks 12, 24, and 52
Number of Participants with Adverse events(Phase two)
Measured: Stage ⅲ ended at about 74 weeks
The interval between stopping the medication and resuming menstruation(Phase two)
Measured: Stage ⅲ ended at about 74 weeks
The amount of menstrual bleeding when the medication was stopped until menstruation resumed(Phase two)
Measured: Stage ⅲ ended at about 74 weeks
Number of days of menstruation from the time of discontinuation of the medication to the time of resumption of menstruation(Phase two)
Measured: Stage ⅲ ended at about 74 weeks
plasma SHR7280 concentration data(Phase two)
Measured: Treatment ended at 4, 24, 36, 52 weeks before administration
serum E2, LH, FSH and P concentrations at each point of view(Phase two)
Measured: Treatment was completed at 4, 8, 12, 16, 20, 24, 36, 44, 52 weeks before administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start10 Sep 2022
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Fibroids With MenorrhagiaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase one：300mg/400mgSHR7280 tablets were compared with placebo Phase two：SHR7280 monotherapy group, SHR7280 reverse therapy group and placebo group were controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 357 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442827
- Sponsor's protocol ID
- SHR7280-301
- Status last verified
- Jan 2024
- First submitted
- 16 Jun 2022
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Phase II/III Clinical Study to Explore the Optimal Therapeutic Dose of SHR7280 Tablets and the Efficacy and Safety of SHR7280 Tablets in Subjects With Menorrhagia for Uterine Fibroids
- ClinicalTrials.gov ID
- NCT05442827
- Acronym / sponsor ID
- SHR7280-301
- Conditions
- Uterine Fibroids With Menorrhagia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 357 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 5 Jul 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Phase one：300mg/400mgSHR7280 tablets were compared with placebo Phase two：SHR7280 monotherapy group, SHR7280 reverse therapy group and placebo group were controlled
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: SHR7280 tablets | Experimental | Drug: SHR7280 tablets |
| Treatment group B:SHR7280 tablets | Experimental | Drug: SHR7280 tablets |
| Treatment group C:Intervention: Drug: PlaceboSHR7280 tablets blank preparation | Placebo comparator | Drug: PlaceboSHR7280 tablets blank preparation |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The informed consent has been signed and dated;
- Non-menopausal women between the ages of 18 and 49 (including 18 and 49);
- Single or multiple uterine fibroids were confirmed by ultrasound examination during screening, and the maximum diameter of at least one fibroid was ≥2 cm;
- Heavy menstrual bleeding measured by the alkaline hematin method during screening;
- 3 months before screening, the subject's menstrual cycle is 21-38 days, and the period is no more than 14 days;
Key exclusion criteria (26 listed)
- Excessive menstrual bleeding and anemia caused by other reasons;
- A history of depression or clinically significant depression;
- Have a history of drug abuse, drug dependence;
- History of smoking and alcohol abuse within 3 months prior to screening;
- A history of delivery, breastfeeding and miscarriage within 6 months prior to screening;
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 |
|---|---|---|
| SHR7280 tabletsSHR7280 tablets 300mg for 12 weeks | Drug | Treatment group A: SHR7280 tablets |
| SHR7280 tabletsSHR7280 tablets 400mg for 12 weeks | Drug | Treatment group B:SHR7280 tablets |
| PlaceboSHR7280 tablets blank preparationPlacebo group: SHR7280 tablets blank preparation for 12 weeks | Drug | Treatment group C:Intervention: Drug: PlaceboSHR7280 tablets blank preparation |
Primary outcome
Phase one：Percentage of subjects with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline
Time frame: After treatment at week 12
Phase two：Percentage of subjects with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline
Time frame: After treatment at week 24
26 secondary outcomes
Percentage of subjects with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline（Phase one）
Time frame: The treatment ended at week 4 and 8
percentage of subjects without menstrual bleeding or spotting （Phase one）
Time frame: The treatment ended at week 4, 8 and 12
Changes in hemoglobin concentration from baseline（Phase one）
Time frame: The treatment ended at week 4, 8 and 12
Changes in uterine volume and maximum fibroid volume from baseline（Phase one）
Time frame: The treatment ended at week 8 and 12
patient global impression of change scale evaluation，The minimum is 1, the maximum is 7, and higher scores mean worse results（Phase one）
Time frame: The treatment ended at week 12
Changes in uterine fibroid symptoms from baseline（Phase one）
Time frame: The treatment ended at week 12
Changes in health related Quality of Life Questionnaire (UFS-QOL) scores from baseline，The minimum is 37 and the maximum is 185, with higher scores indicating worse results（Phase one）
Time frame: The treatment ended at week 12
Number of Participants with Adverse events（Phase one）
Time frame: Stage ⅱ ended, about 30 weeks
The interval between stopping the medication and resuming menstruation（Phase one）
Time frame: Stage ⅱ ended, about 30 weeks
The amount of menstrual bleeding when the medication was stopped until menstruation resumed（Phase one）
Time frame: Stage ⅱ ended, about 30 weeks
Number of days of menstruation from the time of discontinuation of the medication to the time of resumption of menstruation(Phase one)
Time frame: Stage ⅱ ended, about 30 weeks
SHR7280 concentration in plasma(Phase one)
Time frame: Before and at week 4, 8 and 12 after administration
Serum concentrations of estradiol, luteinizing hormone, follicle stimulating hormone and progesterone(Phase one)
Time frame: Before and at week 4, 8 and 12 after administration
Percentage of subjects with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline（Phase two）
Time frame: At the end of weeks 4,8,12,16,20,28,32,36,40,44,48,52
Changes in menstrual bleeding from baseline were assessed using the Alkaline hematin method (AH)（Phase two）
Time frame: At the end of weeks 4,8,12,16,20,24,28,32,36,40,44,48,52
percentage of subjects without menstrual bleeding or spotting (Phase two)
Time frame: Weeks 4,8,12,16,20,24,28,32,36,40,44,48,52
change in Hb concentration from baseline (Phase two）
Time frame: The treatment ended at 4, 8, 12, 16, 20, 24, 36, 44, 52 weeks
Changes in uterine volume and maximum fibroid volume from baseline(Phase two)
Time frame: The treatment ended at weeks 12, 24, and 52
patient global impression of change scale evaluation，The minimum is 1, the maximum is 7, and higher scores mean worse results(Phase two)
Time frame: The treatment ended at weeks 12, 24, and 52
Changes in health related Quality of Life Questionnaire (UFS-QOL) scores from baseline，The minimum is 37 and the maximum is 185, with higher scores indicating worse results(Phase two)
Time frame: The treatment ended at weeks 12, 24, and 52
Number of Participants with Adverse events(Phase two)
Time frame: Stage ⅲ ended at about 74 weeks
The interval between stopping the medication and resuming menstruation(Phase two)
Time frame: Stage ⅲ ended at about 74 weeks
The amount of menstrual bleeding when the medication was stopped until menstruation resumed(Phase two)
Time frame: Stage ⅲ ended at about 74 weeks
Number of days of menstruation from the time of discontinuation of the medication to the time of resumption of menstruation(Phase two)
Time frame: Stage ⅲ ended at about 74 weeks
plasma SHR7280 concentration data(Phase two)
Time frame: Treatment ended at 4, 24, 36, 52 weeks before administration
serum E2, LH, FSH and P concentrations at each point of view(Phase two)
Time frame: Treatment was completed at 4, 8, 12, 16, 20, 24, 36, 44, 52 weeks before administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SHR7280 tablets in people with Uterine Fibroids With Menorrhagia, run by Jiangsu HengRui Medicine 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 7 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 24 Jan 2024. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenyi Zhu (0518-82342973, zhenyi.zhu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase one：Percentage of subjects with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline (time frame: After treatment at week 12). The study lists 2 primary outcomes in all. 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 24 Jan 2024.