Phase 2
N=142
A Study to Assess the Efficacy and Safety of HMI-115 in Subjects With Endometriosis-Associated Pain
Endometriosis
Bottom Line
View on ClinicalTrials.gov: NCT05101317 ↗Enrolled (actual)
142
Serious AEs
0.9%
Results posted
Nov 2025
Primary outcome: Primary: Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change) — -27.35; -34.72; -41.57; -18.61 percentage of change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HMI-115 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Hope Medicine (Nanjing) Co., Ltd
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change) |
-27.35; -34.72; -41.57; -18.61 | — |
| PRIMARY Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12（Absolute Score Change） |
-2.57; -3.29; -3.26; -2.31 | — |
| SECONDARY Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale(NRS) From Baseline to Week 24 (Percentage Change) |
-6.86; -21.82; -14.07; 3.97 | — |
| SECONDARY Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change) |
-33.74; -47.48; -51.66; -27.61; -11.22; -56.62 | — |
| SECONDARY Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change) |
-7.01; -38.43; -11.70; -24.98; -2.32; -61.91 | — |
| SECONDARY Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP |
-0.83; -1.06; -1.13; -0.79; -0.60; -0.87 | — |
| SECONDARY Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use |
-0.656; -0.463; -1.001; -0.384; -0.394; -0.643 | — |
| SECONDARY Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit |
-0.415; -0.571; -0.363; -0.197; -0.119; -0.390 | — |
| SECONDARY Change in Dysmenorrhea(DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 24 (Absolute Score Change) |
-1.87; -2.95; -2.18; -1.45 | — |
| SECONDARY Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change) |
-1.46; -1.64; -1.92; -1.36; -1.21; -2.07 | — |
| SECONDARY Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change) |
-0.23; -1.33; -0.90; -0.54; -1.03; -2.13 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Pre-menopausal female subjects, between 18 and 49 years of age, inclusive, at the time of signing informed consent.
- Subject must have a clinical diagnosis of endometriosis (laparoscopy or laparotomy) as documented by medical records within 10 years before screening.
- Subject must have a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 with a score of at least 2 for DYS and at least 2 for NMPP at screening.
- Subject agrees not to participate in another interventional study while participating in the present study.
Exclusion Criteria
- Subject is pregnant or breastfeeding or is planning a pregnancy during the study period.
- Subject has chronic pelvic pain that is not caused by endometriosis or has any other chronic pain syndrome or other chronic therapy, or that would interfere with the assessment of endometriosis-related pain
- Subject has clinically significant gynecologic condition other than endometriosis
- Subject has previous history of a severe, life-threatening or other significant sensitivity to any opioids or non-steroidal anti inflammatory drugs (NSAIDS) or any contraindication to their use such as gastrointestinal ulcer or bleeding
- Subject has history of hysterectomy and/or bilateral oophorectomy
- Subjects with past or present pituitary tumor growth
- Subjects has a history of osteoporosis or other metabolic bone disease
Data sourced from ClinicalTrials.gov (NCT05101317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.