The Pharmacokinetic(PK)/Pharmacodynamics(PD) Study of SHR7280 Tablets in Premenopausal Subjects With Endometriosis.
Endometriosis
About this trial
This is an interventional treatment trial for Endometriosis
Eligibility Criteria
Inclusion Criteria:
Phase I/II
- premenopausal females, aged 18-45
- History of regular menstrual cycles
- Endometriosis participant diagnosed by surgical (e.g., laparoscopy or laparotomy) or by magnetic resonance imaging or ultrasonography.
- Participant must agree to use only protocol specified rescue analgesics during the Screening and Treatment Periods for endometriosis-associated pain.
- Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on X-ray Phase I (only) Participant has mild or moderate pelvic pain associated with endometriosis at Screening.
Phase II(only) Participant has moderate or severe pelvic pain associated with endometriosis at Screening.
Exclusion Criteria:
Phase I/II
- Subjects with severe trauma or surgery within 6 months prior to the screening;
- Known blood donation within 30 days pre-dose; donating≥200 ml of blood 2 months pre-dose;
- Pregnant or Serum β-human chorionic gonadotropin (hCG)> 5 Million International Units(mIU)/mL at screening or baseline
- Pregnant or breast feeding ;
- Have pelvic pain that is not caused by endometriosis
- Abnormal uterine bleeding
- Are currently receiving gonadotropin-releasing hormone (GnRH) agonist, a GnRH antagonist or danazol or have received any of these agents within 6 months of the start of screening.
- Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening.
- Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within 2 months of the start of screening.
Phase I (only) one month prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs before screening; Phase II (only) Screening dual-energy x-ray absorptiometry (DXA) scan results of the lumbar spine, femoral neck, or total hip bone mineral density corresponding to 1.5 or more standard deviations below normal (T-score at or below -1.5)
Sites / Locations
- Peking University Third HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Placebo Comparator
SHR7280 dose 1
SHR7280 dose 2
SHR7280 dose 3
SHR7280 dose 4
SHR7280 low dose
SHR7280 high dose
Placebo
oral administration for 21days,Phase I
oral administration for 21days,Phase I
oral administration for 21days,Phase I
oral administration for 21days,Phase I
oral administration for 84days,Phase II
oral administration for 84days, Phase II
oral administration for 84days, Phase II