This study is designed to evaluate the safety and efficacy of HMI-115 compared to placebo over a 12 weeks period on subjects with moderate to severe endometriosis-associated pain.
This study aims to evaluate the safety and efficacy of HMI-115 versus a placebo in pre-menopausal women with moderate to severe Endometriosis associated pain. The study will determine the safety and efficacy of HMI 115 at 3 dose levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
142
Physicians' Research Options, LLC- Corner Canyon Clinic
Draper, Utah, United States
Tidewater Clinical Research/TPW
Norfolk, Virginia, United States
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Instytut Matki i Dziecka
Warsaw, Masovian Voivodeship, Poland
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change)
The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: Baseline, Week 12
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12(Absolute Score Change)
The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: Baseline, Week 12
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale(NRS) From Baseline to Week 24 (Percentage Change)
The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: Baseline, Week 24
Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change)
The Numeric Rating Scale for non-menstrual pelvic pain (NMPP) ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: Baseline, week 12 and 24
Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change)
The Numering Rating Score for dyspareunia ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: Baseline, week 12 and 24
Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP
Endometriosis Daily Impact Pain Scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The higher scores mean worse outcome.
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Specjalistyczna Poradnia Ginekologiczna Gabinet Ginekologiczny Dr med. Janusza Tomaszewskiego
Bialystok, Podlaskie Voivodeship, Poland
Time frame: Baseline, week 12 and 24
Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use
Assessment was based on average pill counts at each apecific period od days
Time frame: Baseline, week 12 and 24
Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit
Assessment was based on tampons or pads used. 0 means no bleeding, 4 means heavy bleeding. Higher score means more bleeding.
Time frame: Baseline, week 12 and 24
Change in Dysmenorrhea(DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 24 (Absolute Score Change)
The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: Baseline, Week 24
Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change)
The Numeric Rating Scale (NRS) for non-menstrual pelvic pain (NMPP) ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: Baseline, Week12, Week24
Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change)
The Numering Rating Score(NRS) for dyspareunia(DYSP) ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: Baseline, Week12, Week24