HMI-115 for Endometriosis Pain
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Hope Medicine (Nanjing) Co., Ltd
Must not be taking: Opioids, NSAIDs
Disqualifiers: Pregnancy, Chronic pain, Gynecologic conditions, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is testing HMI-115, a new treatment for reducing pain from endometriosis. It focuses on pre-menopausal women who have moderate to severe pain. The study will test different doses to find the safest and most effective amount.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Research Team
Eligibility Criteria
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.Inclusion Criteria
I am a woman aged 18-49 and have not gone through menopause.
I experience significant pelvic pain and menstrual pain.
Subject agrees not to participate in another interventional study while participating in the present study
See 1 more
Exclusion Criteria
I have a serious gynecological condition that is not endometriosis.
My chronic pelvic pain is not due to endometriosis or any other chronic pain condition.
I have had severe reactions to opioids or NSAIDs, or I can't use them due to stomach issues.
See 4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive HMI-115 or placebo subcutaneously every 2 weeks for 12 weeks
12 weeks
6 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
2 visits (in-person)
Treatment Details
Interventions
- HMI-115 (Unknown)
- Placebo (Drug)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You
Who Is Running the Clinical Trial?
Hope Medicine (Nanjing) Co., Ltd
Lead Sponsor
Trials
3
Recruited
350+
Findings from Research
Depot medroxyprogesterone acetate (DMPA-SC 104) is as effective as leuprolide in reducing endometriosis-associated pain over an 18-month period, with significant improvements in multiple pain categories.
DMPA-SC 104 causes significantly less decline in bone mineral density compared to leuprolide, and BMD levels return to pre-treatment levels 12 months after stopping DMPA-SC 104, indicating a safer profile for bone health.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Subcutaneous depot medroxyprogesterone acetate versus leuprolide acetate in the treatment of endometriosis-associated pain.Crosignani, PG., Luciano, A., Ray, A., et al.[2022]
A network meta-analysis of 36 randomized controlled trials involving 7942 patients found that dienogest, combined hormonal contraceptives (CHCs), and elagolix were the most effective treatments for reducing pelvic pain related to endometriosis at three months.
Gonadotropin-releasing hormone (GnRH) analogues were ranked highest for reducing dysmenorrhea at three months and CHCs at six months, indicating that these treatments are effective options for managing various types of endometriosis-related pain.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Medical therapy options for endometriosis related pain, which is better? A systematic review and network meta-analysis of randomized controlled trials.Samy, A., Taher, A., Sileem, SA., et al.[2021]
A systematic review of 58 articles involving women treated for endometriosis-associated pain revealed that 11%-19% of patients experienced no reduction in pain, and 5%-59% still had pain at the end of treatment.
Despite some benefits, many women only experienced limited or intermittent relief from symptoms, with 17%-34% experiencing pain recurrence after treatment cessation, highlighting the need for better reporting of patient-relevant outcomes in studies.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Reevaluating response and failure of medical treatment of endometriosis: a systematic review.Becker, CM., Gattrell, WT., Gude, K., et al.[2022]
References
Subcutaneous depot medroxyprogesterone acetate versus leuprolide acetate in the treatment of endometriosis-associated pain. [2022]
Medical therapy options for endometriosis related pain, which is better? A systematic review and network meta-analysis of randomized controlled trials. [2021]
The ENDOPAIN 4D Questionnaire: A New Validated Tool for Assessing Pain in Endometriosis. [2021]
Reevaluating response and failure of medical treatment of endometriosis: a systematic review. [2022]
CHC for pelvic pain in women with endometriosis: ineffectiveness or discontinuation due to side-effects. [2022]