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

Last updated: September 11, 2024
Sponsor: Hope Medicine (Nanjing) Co., Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

Endometriosis

Treatment

HMI-115

Placebo

Clinical Study ID

NCT05101317
HMI-115EM201
  • Ages 18-49
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Pre-menopausal female subjects, between 18 and 49 years of age, inclusive, at thetime 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 ≥ 6with 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 whileparticipating in the present study.

Exclusion

Exclusion Criteria:

  1. Subject is pregnant or breastfeeding or is planning a pregnancy during the studyperiod.

  2. Subject has chronic pelvic pain that is not caused by endometriosis or has any otherchronic pain syndrome or other chronic therapy, or that would interfere with theassessment 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 significantsensitivity to any opioids or non-steroidal anti inflammatory drugs (NSAIDS) or anycontraindication 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

Study Design

Total Participants: 152
Treatment Group(s): 2
Primary Treatment: HMI-115
Phase: 2
Study Start date:
October 11, 2021
Estimated Completion Date:
April 30, 2025

Study 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.

Part 1 of the study will determine the safety and efficacy of HMI 115 at 3 dose levels. Part 2 will detect a higher dose and might be conducted after Part 1.

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100703
    China

    Active - Recruiting

  • HopeMed HopeMed

    Nanjing, Utah 84020-7163
    China

    Site Not Available

  • Instytut Matki i Dziecka

    Warszawa, Mazowieckie
    Poland

    Completed

  • Specjalistyczna Poradnia Ginekologiczna Gabinet Ginekologiczny Dr med. Janusza Tomaszewskiego

    Bialystok, Podlaskie
    Poland

    Completed

  • Gtc Research

    Shawnee Mission, Kansas 66218
    United States

    Site Not Available

  • Complete Healthcare For Woman

    Columbus, Ohio 43231
    United States

    Site Not Available

  • Cedar Health Research

    Dallas, Texas 75251
    United States

    Site Not Available

  • The Woman's Hospital of Texas Clinical Research Center

    Houston, Texas 77024
    United States

    Site Not Available

  • Complete Healthcare For Woman

    Kingwood, Texas 77339-1510
    United States

    Site Not Available

  • Physicians' Research Options, LLC- Corner Canyon Clinic

    Draper, Utah 84020
    United States

    Completed

  • Tidewater Clinical Research/TPW

    Norfolk, Virginia 23502
    United States

    Completed

  • Seattle Women's: Health, Research, Gynecology

    Seattle, Washington 98105
    United States

    Site Not Available

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