RecruitingPhase 3interventionalRules rewrite

Phase 3: testing HMI-115 for Endometriosis

A phase 3 study to measure the how well it works 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

Official registry: https://clinicaltrials.gov/study/NCT07318688 · Hope Medicine (Nanjing) Co., Ltd · enrollment listed as 540

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are HMI-115, or Placebo. The registry lists allocation as randomized. A phase 3 study to measure the how well it works 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

They plan to enroll about 540 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: HMI-115, Placebo

Primary outcome (registry wording): Change from Baseline (CFB) in dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) at Week 12

Who it is for (from inclusion criteria)

Ages 18 Years to 49 Years
Women only
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
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 compared with a dummy treatment neither you nor the study doctors know who gets the real treatment treatment period and assessments at Week 24

Who the registry excludes

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
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

Public study contact (from the registry)

Xu Yeqing

86-18717858198

yeqing.xu@hopemedinc.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

5 listed

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)
Second Affiliated Hospital of Soochow University — Suzhu, Jiangsu, China (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)

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FAQ about this NCT record

Is NCT07318688 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07318688?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07318688?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary