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A Study to Assess the Efficacy and Safety of HMI-115 in Subjects With Endometriosis-Associated Pain | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT05101317•Hope Medicine (Nanjing) Co., Ltd

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

18 - 49 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Pre-menopausal female subjects, between 18 and 49 years of age, inclusive, at the time of signing informed consent.
•2. Subject must have a clinical diagnosis of endometriosis (laparoscopy or laparotomy) as documented by medical records within 10 years before screening.
•3. 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.
•4. Subject agrees not to participate in another interventional study while participating in the present study.

Exclusion Criteria

•1. Subject is pregnant or breastfeeding or is planning a pregnancy during the study period.
•2. 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
•3. Subject has clinically significant gynecologic condition other than endometriosis
•4. 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
•5. Subject has history of hysterectomy and/or bilateral oophorectomy
•6. Subjects with past or present pituitary tumor growth
•7. Subjects has a history of osteoporosis or other metabolic bone disease

Locations (5)

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

Specjalistyczna Poradnia Ginekologiczna Gabinet Ginekologiczny Dr med. Janusza Tomaszewskiego

Bialystok, Podlaskie Voivodeship, Poland

Key Dates

Start Date

October 11, 2021

Primary Completion Date

September 26, 2024

Completion Date

March 19, 2025

Last Updated

January 21, 2026

Enrollment

142

ACTUAL participants

Conditions

Endometriosis

Interventions

HMI-115

DRUG

Placebo

DRUG

The Developmental Origins of Endometriosis

NCT05951452

Endometriosis

View study

RECRUITINGPHASE2

Glycemic Regulation as Endometriosis Adjunct Treatment

NCT06611501

Pelvic PainEndometriosis

View study

RECRUITINGPHASE3

The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess the Efficacy and Safety of HMI-115 in Subjects With Endometriosis-Associated Pain

Inclusion Criteria

Exclusion Criteria

The Developmental Origins of Endometriosis

Glycemic Regulation as Endometriosis Adjunct Treatment

The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)

Effect of Tele-Yoga on Pain, Fatigue, and Quality of Life in Endometriosis

Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer

Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas