Trial studying safety and effects for Endometriosis
Official title Evaluate the Efficacy and Safety of HMI-115 in Women With Moderate to Severe Endometriosis-associated Pain
ClinicalTrials.gov ID: NCT07318688
What this study is testing
What is HMI-115?
HMI-115 is an investigational medicine, being studied as a potential treatment for endometriosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A 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
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 49, women only
You may be able to join if
- 1\. Premenopausal female people, 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.
You likely can't join if
- 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...
- 2\. Subject has an intra-uterine device (IUD). Subject is eligible if she removes the IUD 1 month before screening.
- 3\. Subject has chronic pelvic pain that is not caused by endometriosis (e.g., interstitial cystitis, irritable bowel syndrome) or has any other...
- 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.
See the full eligibility criteria
Who can join
- 1\. Premenopausal female people, 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.
- 6\. Subject agrees to use required (nonhormonal) birth control methods during the entire length of participation in the study and agrees to avoid pregnancy from signing the informed consent until 12 weeks after the last...
- 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 an inactive treatment blinded treatment period and assessments at Week 24.
What rules you out
- 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...
- 2\. Subject has an intra-uterine device (IUD). Subject is eligible if she removes the IUD 1 month before screening.
- 3\. Subject has chronic pelvic pain that is not caused by endometriosis (e.g., interstitial cystitis, irritable bowel syndrome) or has any other chronic pain syndrome (e.g., fibromyalgia, chronic back pain, myofascial...
- 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...
- 8\. Subject with known hypersensitivity to any of the IMP ingredients.
- 9\. Subject has an estimated glomerular filtration rate (eGFR) of \< 60mL/min/1.73 m2 at Screening Period.
- 10\. Subject is currently participating in or has participated in an treatment clinical study with an investigational compound or device within 30 days prior to the start of Screening Period or 5 half-lives, whichever...
- 11\. Subject who has been exposed to HMI-115 treatment.
- 12\. Subject has used medications such as hormones, analgesics, medications associated with bone loss, products that affect PRL levels, etc. within specific time window before Screening.
- 13\. Subject has clinically significantly abnormal laboratory tests at Screening Period, including:
- Alanine transaminase (ALT/SGPT), or aspartate aminotransferase (AST/SGOT) ≥200% of the upper limit of normal, or total bilirubin (unless known diagnosis of Gilbert's syndrome) ≥ 150% of the upper limit of normal range.
- Hemoglobin \< 100 g/L, Neutrophil count \< 1.5×109/ L, Platelet count \< 100×109/ L.
- 14\. Subject has clinically significantly abnormal laboratory tests at Screening Period, including: Neutrophil count \< 1.5×109/ L, Platelet count \< 100×109/ L.
- 15\. Subject has clinically significant abnormal ECG, or ECG with QTcF \> 450 msec at Screening Period.
- 16\. Subject has a history or current has malignancy except for treated basal cell carcinoma and cutaneous squamous cell carcinoma of the skin.
- 17\. Subject is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the study.
- 18\. Subject has any of the following conditions within the last 6 months before Screening:
- Myocardial infarction, stroke, unstable angina or transient ischemic attack.
- Classified as being in New York Heart Association Class III or IV.
- 19\. people with body weight greater than 300 pounds or 136 kilograms.
- 20\. Any other conditions in the Investigator's opinion that prevent the subject from participating.
- 21\. Criteria for Extension Treatment Period： people entering the follow-up period after treatment: people with a BMD decrease of ≥ 8.0% or Z-value ≤ -2.0 in any part of the lumbar spine, femoral neck, or total hip...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Nanning, Jiangsu, China
- Suzhu, Jiangsu, China
- Shanghai, Shanghai Municipality, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 49 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Nanning, Jiangsu, China; Suzhu, Jiangsu, China; Shanghai, Shanghai Municipality, China; Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.