RecruitingNCT05442827Updated Jan 24, 2024

A Phase II/III Study of Efficacy and Safety of SHR7280 Tablets in Subjects With Menorrhagia With Uterine Fibroids

A Phase 2/3 interventional study of SHR7280 tablets and SHR7280 tablets in Uterine Fibroids With Menorrhagia, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Recruiting at 1 site in China. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2024-01-24.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 2/3, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
Started Sep 2022; still recruiting 4 years later.

Phase: Phase 2/3
Study type: Interventional
Enrollment: 357
Allocation: Randomized
Ages: 18 Years to 49 Years
Sex: Female

Study 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 phase II studies.

Conditions studied

Uterine Fibroids With Menorrhagia

Browse trials for

In context

Leiomyoma

490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.

This study's planned enrollment of 357 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.

Browse Leiomyoma studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 49 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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;
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.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 357 participants (estimated)

Study arms

Experimental
Treatment group A: SHR7280 tablets
Drug: SHR7280 tablets
Experimental
Treatment group B:SHR7280 tablets
Drug: SHR7280 tablets
Placebo comparator
Treatment group C:Intervention: Drug: PlaceboSHR7280 tablets blank preparation
Drug: PlaceboSHR7280 tablets blank preparation

Interventions

DrugSHR7280 tablets
SHR7280 tablets 300mg for 12 weeks
DrugSHR7280 tablets
SHR7280 tablets 400mg for 12 weeks
DrugPlaceboSHR7280 tablets blank preparation
Placebo group: SHR7280 tablets blank preparation for 12 weeks

What researchers measure

Primary outcomes

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

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

Study locations

1 of 1 sites recruiting

Peking University First Hospital
Beijing, Beijing 100034, China
- Yingfang Zhou · Principal investigator
- Chao Peng · Principal investigator
Recruiting

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05442827
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Responsible party: Sponsor
First posted: Jul 5, 2022
Start date: Sep 10, 2022
Primary completion: Jun 1, 2026 (estimated)
Completion: Jun 1, 2026 (estimated)
Last update: Jan 24, 2024

Study contacts

Zhenyi Zhu

Contact

zhenyi.zhu@hengrui.com

0518-82342973

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Leiomyoma→

Other studies from this sponsor

Jiangsu HengRui Medicine Co., Ltd.

Start the discussion