See if HMI-115 helps women with moderate to severe endometriosis pain
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of HMI-115 in Women With Moderate to Severe Endometriosis-Associated Pain Over a 24-Week Treatment Period and a 28-Week Extension
Run by Hope Medicine (Nanjing) Co., Ltd · NCT07318688 · Data updated 2026-11-12
This phase 3 study tests whether HMI-115 reduces endometriosis-related pain in premenopausal women compared with placebo over 24 weeks, with a follow-up extension.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 49 Years |
| Sex | Women only |
| Enrollment | 540 (estimated) |
| Sponsor | Hope Medicine (Nanjing) Co., Ltd Industry-sponsored |
| Locations | 5 sites (Beijing, Beijing Municipality and 4 other locations) |
| Status | Recruiting |
| Started | January 29, 2026 |
| Main results expected | March 1, 2028 |
| Study ends | September 1, 2028 |
| Registry record updated | August 11, 2026 |
| Trial ID | NCT07318688 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Premenopausal women aged 18–49 with a surgical diagnosis of endometriosis and moderate to severe pain who agree to nonhormonal contraception and comply with study procedures.
✕Probably not a fit
Individuals who do not experience a reduction in pain or who experience adverse effects may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, placebo-controlled trial focuses on women aged 18 to 49 with a surgical diagnosis of endometriosis and moderate to severe pelvic pain. Participants will receive HMI-115 or placebo for 24 weeks, followed by a 28-week extension to monitor ongoing effects and safety. The study uses a composite score of pelvic signs and symptoms to select eligible participants and assesses pain during treatment. Nonhormonal birth control is required, and contraception continues through the post-treatment period. Primary outcomes center on changes in pain and safety signals over the treatment period.
Why it matters
Potential benefit: If successful, participants may experience reduced endometriosis-related pain and improved daily functioning during and after treatment.
How similar studies have gone: Prior similar approaches in endometriosis have shown mixed results; this study aims to provide more definitive evidence in a Phase 3 setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Premenopausal female subjects, between 18 and 49 years of age, inclusive. * 2\. Has a surgical diagnosis of endometriosis (laparoscopy or laparotomy) as documented by medical records within 10 years before screening. * 3\. Has a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 at screening with a score of at least 2 for DYS and at least 2 for NMPP. * 4\. Subject has reported "moderate" or "severe" for her endometriosis-associated DYS AND NMPP before randomization. * 5\. Subject has at least two consecutive regular menstrual cycle (i.e. 21 to 35 days in duration) prior to randomization. * 6\. Subject agrees to use required (nonhormonal) birth control methods during the entire length of participation in the study and agrees to avoid pregnancy from signing the informed consent until 12 weeks after the last dose. * 7\. Subject agrees to use only those rescue analgesic medications permitted by the protocol during the Screening, Treatment and Posttreatment follow-up Periods for her endometriosis-associated pain. * 8\. Criteria for Extension Treatment Period:Subject who completes treatment of the placebo-controlled double-blind treatment period and assessments at Week 24. Exclusion Criteria: * 1\. Subject who is pregnant or breastfeeding or is planning a pregnancy during the study period or is less than 6 months post-partum or 3 months post-abortion at the time of entry into the Screening Period or pregnancy before randomization. * 2\. Subject has an intra-uterine device (IUD). Subject is eligible if she removes the IUD 1 month before screening. * 3\. Subject has chronic pelvic pain that is not caused by endometriosis (e.g., interstitial cystitis, irritable bowel syndrome) or has any other chronic pain syndrome (e.g., fibromyalgia, chronic back pain, myofascial pain syndrome, chronic headaches) that requires chronic analgesic or other chronic therapy, which would interfere with the assessment of endometriosis-associated pain. * 4\. Subject with a current history of undiagnosed abnormal genital bleeding. * 5\. Subject with history of hysterectomy and/or bilateral oophorectomy. * 6\. Subject has had surgery for endometriosis within 6 weeks prior to entry into the Screening Period. * 7\. 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. * 8\. Subject with known hypersensitivity to any of the IMP ingredients. * 9\. Subject has an estimated glomerular filtration rate (eGFR) of \< 60mL/min/1.73 m2 at Screening Period. * 10\. Subject is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days prior to the start of Screening Period or 5 half-lives, whichever is longer. * 11\. Subject who has been exposed to HMI-115 treatment. * 12\. Subject has used medications such as hormones, analgesics, medications associated with bone loss, products that affect PRL levels, etc. within specific time window before Screening. * 13\. Subject has clinically significantly abnormal laboratory tests at Screening Period, including: 1. Alanine transaminase (ALT/SGPT), or aspartate aminotransferase (AST/SGOT) ≥200% of the upper limit of normal, or total bilirubin (unless known diagnosis of Gilbert's syndrome) ≥ 150% of the upper limit of normal range. 2. Hemoglobin \< 100 g/L, Neutrophil count \< 1.5×109/ L, Platelet count \< 100×109/ L. * 14\. Subject has clinically significantly abnormal laboratory tests at Screening Period, including: Neutrophil count \< 1.5×109/ L, Platelet count \< 100×109/ L. * 15\. Subject has clinically significant abnormal ECG, or ECG with QTcF \> 450 msec at Screening Period. * 16\. Subject has a history or current has malignancy except for treated basal cell carcinoma and cutaneous squamous cell carcinoma of the skin. * 17\. Subject is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the study. * 18\. Subject has any of the following conditions within the last 6 months before Screening: 1. Myocardial infarction, stroke, unstable angina or transient ischemic attack. 2. Classified as being in New York Heart Association Class III or IV. * 19\. Subjects with body weight greater than 300 pounds or 136 kilograms. * 20\. Any other conditions in the Investigator's opinion that prevent the subject from participating. * 21\. Criteria for Extension Treatment Period: Subjects entering the follow-up period after treatment: subjects with a BMD decrease of ≥ 8.0% or Z-value ≤ -2.0 in any part of the lumbar spine, femoral neck, or total hip compared to baseline.
Where it's running
-
Second Affiliated Hospital of Soochow University
Suzhu, Jiangsu, China Recruiting -
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China Not yet recruiting -
Nanjing Women and children's healthcare hospital
Nanning, Jiangsu, China Not yet recruiting -
The International Peace Maternity and Child Health Hospital of the China Welfare Institute
Shanghai, Shanghai Municipality, China Not yet recruiting -
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China Not yet recruiting
Study contacts
- Study coordinator: Xu Yeqing
- Email: yeqing.xu@hopemedinc.com
- Phone: 86-18717858198
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing different techniques to treat endometriosis
This study is testing different methods to treat endometriosis, like laser and heat techniques, to see which one works best for relieving pain in women who are already having surgery for the condition.
-
Postoperative Pain Trajectories After Endometriosis Surgery
This study tests how pain changes after endometriosis surgery and whether perioperative pain testing can predict who will have ongoing pain.
-
Imaging endometriosis with a special PET tracer in adult women
This study tests whether a PET/CT scan using [18F]AlF-FAPI-74 can help detect endometriosis lesions in women who are planning laparoscopy.
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Fiber supplement for digestive symptoms in endometriosis
A fiber-based supplement is being tested to see if it is safe and helps with gut and vaginal microbiomes and digestive symptoms in women with endometriosis.
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Stellate ganglion block and dexmedetomidine for better sleep after gynecologic laparoscopy
The study tests whether giving a preoperative stellate ganglion block plus intraoperative dexmedetomidine improves sleep after laparoscopic gynecologic surgery in women.
-
Atypical Endometriosis: Histology, Immunophenotype and Molecular Features
Researchers will look at how endometriotic tissue that looks atypical under the microscope relates to clinical features and ultrasound findings to better separate benign from potentially atypical lesions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.