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HMI-115 for Endometriosis Pain

Phase 2
Recruiting
Research Sponsored by Hope Medicine (Nanjing) Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pre-menopausal female subjects, between 18 and 49 years of age, inclusive, at the time of signing informed consent
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12 and 24
Awards & highlights

Study Summary

This trial will study whether HMI-115 is safe and effective in treating endometriosis-associated pain.

Who is the study for?
This trial is for pre-menopausal women aged 18-49 with a documented diagnosis of endometriosis and moderate to severe pain. They must not be pregnant, planning pregnancy, or breastfeeding, and should have no history of hysterectomy, oophorectomy, osteoporosis, other chronic pain conditions that could affect the study's outcome.Check my eligibility
What is being tested?
The trial tests HMI-115 against a placebo over 12 weeks to see if it can safely reduce pain associated with endometriosis. Participants will randomly receive either the drug or placebo without knowing which one they are taking.See study design
What are the potential side effects?
While specific side effects for HMI-115 aren't listed here, common side effects in trials like this may include nausea, headache, digestive issues or allergic reactions. The severity can range from mild to serious.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 18-49 and have not gone through menopause.
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I experience significant pelvic pain and menstrual pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12 and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) from Baseline to Week 12
Secondary outcome measures
CFB by visit in permitted rescue medication use
Change from Baseline (CFB) in the monthly mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP
Change in DYS measured by NRS from Baseline to Week 24
+3 more

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: HMI-115 60mgActive Control1 Intervention
Once Every 2 weeks, subcutaneously injection
Group II: HMI-115 120mgActive Control1 Intervention
Once Every 2 weeks, subcutaneously injection
Group III: HMI-115 240mgActive Control1 Intervention
Once Every 2 weeks, subcutaneously injection
Group IV: PlaceboPlacebo Group1 Intervention
Once Every 2 weeks, subcutaneously injection

Find a Location

Who is running the clinical trial?

Hope Medicine (Nanjing) Co., LtdLead Sponsor
2 Previous Clinical Trials
196 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor have open enrollment at the moment?

"Affirmative. According to records hosted on clinicaltrials.gov, this investigation began October 11th 2021 and is currently seeking participants. A total of 152 patients are required across 9 different medical centres."

Answered by AI

What is the regulatory status of HMI-115 240mg?

"There is an extant body of evidence in support of HMI-115 240mg's safety, yet no confirmed efficacy data. As a result, it was assigned a score 2 on our team's assessment scale."

Answered by AI

Is this trial enrolling individuals aged 40 or older?

"This clinical trial is available for participants aged 18 to 49. There are 4 trials that accept patients under 18 and 13 other studies enrolling those above 65 years old."

Answered by AI

Who qualifies to partake in this experiment?

"This medical research is searching for 152 individuals aged 18 to 49 with endometrioma. Those interested must fulfil the following requirements: be willing not to participate in any other trials while enrolled, have a Composite Pelvic Signs and Symptoms Score of 6 or more with at least 2 points allocated to DYS and NMPP, possess records detailing their clinical diagnosis of endometriosis (confirmed via laparoscopy/laparotomy) within 10 years of screening."

Answered by AI

What is the scope of participant recruitment for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical trial is still seeking suitable candidates for participation - it was first initialised on October 11th 2021 and has since been modified on March 30th 2022. 152 individuals need to be enrolled from 9 different research sites."

Answered by AI

How extensive is the scope of this clinical trial's implementation in hospitals?

"This trial is currently being conducted in 9 different locations, such as Cedar Health Research Center of Dallas, The Woman's Hospital of Texas Clinical Research Centre of Houston and GTC Research Institute of Shawnee Mission. There are 6 other sites hosting the study."

Answered by AI

What overarching goals is this research endeavor hoping to achieve?

"As indicated by the clinical trial sponsor, Hope Medicine (Nanjing) Co., Ltd, this study will measure Change of dysmenorrhea (DYS), scored on a Numeric Rating Scale from 0 to 10 with higher scores indicating worse outcomes, at Baseline and Week 12 as its primary outcome. Additionally, secondary endpoints such as Change in dyspareunia (DYSP) measured over a Baseline-Week 12 interval and Change of non-menstrual pelvic pain (NMPP) utilizing NRS from Baseline to Week 24 are being evaluated."

Answered by AI

Who else is applying?

What state do they live in?
Washington
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Complete Healthcare For Woman

Why did patients apply to this trial?

I experience a lot of pain and bloating, and I don’t want to get another surgery.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Efficacy and Safety of HMI-115 in Subjects With Endometriosis-Associated Pain
2021. "A Study to Assess the Efficacy and Safety of HMI-115 in Subjects With Endometriosis-Associated Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05101317.
All > Endometriosis
~29 spots leftby Dec 2024
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