This study is designed to evaluate the safety and efficacy of GenSci048 for moderate to severe endometriosis-associated pain treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGChange of dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS)
The NRS for overall endometriosis-associated pain ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: baseline, week 24
Change of non-menstrual pelvic pain (NMPP) measured by Numeric Rating Scale (NRS)
The NRS for overall endometriosis-associated pain ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: baseline, week 24
Change of DYS, NMPP, and dyspareunia (DYSP) measured by Numeric Rating Scale (NRS). The NRS for overall endometriosis-associated pain ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: 52 weeks
Permitted rescue medication use.
Time frame: 52 weeks
Patient Global Impression of Change, Patient Global Impression of Change (minimum 1, maximum 7, higher score mean a worse outcome).
Time frame: Week 12、Week 24、Week 52
Adverse Event
Time frame: up to approximately 56 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.