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New hope for endometriosis sufferers: drug trial targets severe pain

NCT ID NCT05101317

Symptom relief Sponsor: Hope Medicine (Nanjing) Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called HMI-115 in 142 women with moderate-to-severe endometriosis pain. Over 12 weeks, researchers compared the drug to a placebo to see if it safely reduces pain during periods and pelvic pain. The goal is to find a new treatment option for this chronic condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

142 people

The number who actually took part.

Started

Oct 2021

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 49 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

endometriosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometriosis

Contacts and locations

Locations

  • Instytut Matki i Dziecka

    Warsaw, Masovian Voivodeship, Poland

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100703, China

  • Physicians' Research Options, LLC- Corner Canyon Clinic

    Draper, Utah, 84020, United States

  • Specjalistyczna Poradnia Ginekologiczna Gabinet Ginekologiczny Dr med. Janusza Tomaszewskiego

    Bialystok, Podlaskie Voivodeship, Poland

  • Tidewater Clinical Research/TPW

    Norfolk, Virginia, 23502, United States

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