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

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Conditions

Endometriosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-11
Study Completion:2025-03-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05101317

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 49 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Pre-menopausal female subjects, between 18 and 49 years of age, inclusive, at the time of signing informed consent.
  2. 2. Subject must have a clinical diagnosis of endometriosis (laparoscopy or laparotomy) as documented by medical records within 10 years before screening.
  3. 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. 4. Subject agrees not to participate in another interventional study while participating in the present study.
  1. 1. Subject is pregnant or breastfeeding or is planning a pregnancy during the study period.
  2. 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. 3. Subject has clinically significant gynecologic condition other than endometriosis
  4. 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. 5. Subject has history of hysterectomy and/or bilateral oophorectomy
  6. 6. Subjects with past or present pituitary tumor growth
  7. 7. Subjects has a history of osteoporosis or other metabolic bone disease

Contacts and Locations

Study Locations (Sites)

Physicians' Research Options, LLC- Corner Canyon Clinic
Draper, Utah, 84020
United States
Tidewater Clinical Research/TPW
Norfolk, Virginia, 23502
United States

Collaborators and Investigators

Sponsor: Hope Medicine (Nanjing) Co., Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-11
Study Completion Date2025-03-19

Study Record Updates

Study Start Date2021-10-11
Study Completion Date2025-03-19

Terms related to this study

Additional Relevant MeSH Terms

  • Endometriosis