Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: SHR7280 tablets | Experimental |
| |
| Treatment group B:SHR7280 tablets | Experimental |
| |
| Treatment group C:Intervention: Drug: PlaceboSHR7280 tablets blank preparation | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR7280 tablets | Drug | SHR7280 tablets 300mg for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase one:Percentage of subjects with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline | After treatment at week 12 | |
| Phase two:Percentage of subjects with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline | After treatment at week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline(Phase one) | The treatment ended at week 4 and 8 | |
| percentage of subjects without menstrual bleeding or spotting (Phase one) | The treatment ended at week 4, 8 and 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenyi Zhu | Contact | 0518-82342973 | zhenyi.zhu@hengrui.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase one:300mg/400mgSHR7280 tablets were compared with placebo Phase two:SHR7280 monotherapy group, SHR7280 reverse therapy group and placebo group were controlled
Not provided
Not provided
Not provided
| SHR7280 tablets |
| Drug |
SHR7280 tablets 400mg for 12 weeks |
|
| PlaceboSHR7280 tablets blank preparation | Drug | Placebo group: SHR7280 tablets blank preparation for 12 weeks |
|
| Changes in hemoglobin concentration from baseline(Phase one) | The treatment ended at week 4, 8 and 12 |
| Changes in uterine volume and maximum fibroid volume from baseline(Phase one) | 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) | The treatment ended at week 12 |
| Changes in uterine fibroid symptoms from baseline(Phase one) | 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) | The treatment ended at week 12 |
| Number of Participants with Adverse events(Phase one) | Stage ⅱ ended, about 30 weeks |
| The interval between stopping the medication and resuming menstruation(Phase one) | Stage ⅱ ended, about 30 weeks |
| The amount of menstrual bleeding when the medication was stopped until menstruation resumed(Phase one) | 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) | Stage ⅱ ended, about 30 weeks |
| SHR7280 concentration in plasma(Phase one) | Before and at week 4, 8 and 12 after administration |
| Serum concentrations of estradiol, luteinizing hormone, follicle stimulating hormone and progesterone(Phase one) | 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) | 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) | 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) | Weeks 4,8,12,16,20,24,28,32,36,40,44,48,52 |
| change in Hb concentration from baseline (Phase two) | 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) | 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) | 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) | The treatment ended at weeks 12, 24, and 52 |
| Number of Participants with Adverse events(Phase two) | Stage ⅲ ended at about 74 weeks |
| The interval between stopping the medication and resuming menstruation(Phase two) | Stage ⅲ ended at about 74 weeks |
| The amount of menstrual bleeding when the medication was stopped until menstruation resumed(Phase two) | 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) | Stage ⅲ ended at about 74 weeks |
| plasma SHR7280 concentration data(Phase two) | Treatment ended at 4, 24, 36, 52 weeks before administration |
| serum E2, LH, FSH and P concentrations at each point of view(Phase two) | Treatment was completed at 4, 8, 12, 16, 20, 24, 36, 44, 52 weeks before administration |