NCT05101317CompletedPhase 2
A Study to Assess the Efficacy and Safety of HMI-115 in Subjects With Endometriosis-Associated Pain
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of HMI-115 in Women With Moderate to Severe Endometriosis-Associated Pain Over a 12-Week Treatment Period
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 142 (actual)
- First submitted
- 9 Oct 2021
- Start date
- 11 Oct 2021
- Primary completion date
- 26 Sept 2024
- Lead sponsor
- Hope Medicine (Nanjing) Co., Ltd
- Diseases
- Endometriosis
- NCT number
- NCT05101317
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 142
- From 11 Oct 2021 to the primary completion date, 26 Sept 2024
- 5 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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 history of hysterectomy and/or bilateral oophorectomy
- Subjects has a history of osteoporosis or other metabolic bone disease
Other
- Subject is pregnant or breastfeeding or is planning a pregnancy during the study period.
- Subjects with past or present pituitary tumor growth
Who the study is looking for
- 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.
Age in the registry: 18 years to 49 years · Sex: Female · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Specjalistyczna Poradnia Ginekologiczna Gabinet Ginekologiczny Dr med. Janusza Tomaszewskiego Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| Instytut Matki i Dziecka Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Physicians' Research Options, LLC- Corner Canyon Clinic Coordinator of this site? Confirm its status | Draper | United States | Unknown status |
| Tidewater Clinical Research/TPW Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.