The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in premenopausal subjects with endometriosis. In addition, this study will provide information on efficacy of SHR7280 tablets in premenopausal subjects with endometriosis.
Endometriosis is a common disease, affecting 5-10% of women of reproductive age . It is an estrogen-dependent and estrogen-driven disease and so hormonal manipulation and suppression of estrogen production form the basis of the majority of medical treatment. The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in premenopausal subjects with endometriosis. In addition, this study will provide information on efficacy of SHR7280 tablets in premenopausal subjects with endometriosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
179
treatment
blank control
Peking University Third Hospital
Beijing, Beijing Municipality, China
Number of Participants with Adverse events
Phase I
Time frame: Pre-dose to 28±2 days after dose administration
Change From Baseline in the 7-day mean score for pelvic pain as measured by VAS at weeks 12
Phase II daily assessment of dysmenorrhea score on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) using an e-Diary.
Time frame: Baseline and weeks 12
PK markers of SHR7280: area under the plasma concentration versus time curve (AUC)
Phase I \& II
Time frame: At pre-defined intervals from initial dose through final study visit
PK markers of SHR7280: time to maximum plasma concentration(Tmax)
Phase I \& II
Time frame: At pre-defined intervals from initial dose through final study visit
PK markers of SHR7280: maximum plasma concentration(Cmax)
Phase I \& II
Time frame: At pre-defined intervals from initial dose through final study visit
PK markers of SHR7280: half-time(t1/2)
Phase I \& II
Time frame: At pre-defined intervals from initial dose through final study visit
PK markers of SHR7280: apparent clearance(CL/F)
Phase I \& II
Time frame: At pre-defined intervals from initial dose through final study visit
PK markers of SHR7280: apparent volume of distribution(Vz/F)
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Phase I \& II
Time frame: At pre-defined intervals from initial dose through final study visit
PD markers of SHR7280: Concentration of Estradiol(E2)
Phase I \& II
Time frame: At pre-defined intervals from initial dose through final study visit
PD markers of SHR7280: Concentration of Progesterone(P)
Phase I \& II
Time frame: At pre-defined intervals from initial dose through final study visit
PD markers of SHR7280: Concentration of Follicle stimulating hormone(FSH)
Phase I \& II
Time frame: At pre-defined intervals from initial dose through final study visit
PD markers of SHR7280: Concentration of Luteinizing hormone(LH)
Phase I \& II
Time frame: At pre-defined intervals from initial dose through final study visit
Change From Baseline in the 7-day mean score for pelvic pain as measured by VAS
Phase II
Time frame: Baseline and weeks 4、8
Change From Baseline in the Monthly Mean score for pelvic pain as measured by VAS
Phase II
Time frame: Baseline and weeks 4、8、12
Change From Baseline in the Monthly Mean Dysmenorrhea Score
Phase II
Time frame: Baseline and weeks 8、12
Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score and Dyspareunia Score
Phase II
Time frame: Baseline and weeks 4、8、12
Change from baseline to monthly analgesic use to treat endometriosis-associated pain
Phase II
Time frame: Baseline and weeks 4、8、12
Patient Global Impression of Change (PGIC) score at week 12
Phase II
Time frame: Week 12
Adverse events
Time frame: during Pre and 28±3 days after dose administration