What side effects are associated with this type of intervention?

Common treatments for endometriosis include combined estrogen-progestin contraceptives, progestins, GnRH agonists and antagonists, and NSAIDs. Combined estrogen-progestin contraceptives can cause side effects such as nausea, breast tenderness, and an increased risk of blood clots. Progestins may lead to weight gain, mood changes, and irregular bleeding. GnRH agonists and antagonists are associated with menopausal-like symptoms, including hot flashes, decreased bone density, and mood swings. NSAIDs, while generally well-tolerated, can cause gastrointestinal issues such as stomach pain, ulcers, and bleeding. Each treatment has its own risk profile, and patients should discuss these with their healthcare provider to determine the best option for their individual needs.

What prior FDA approvals exist?

The FDA has approved several treatments for endometriosis, primarily focusing on hormonal therapies. These include Gonadotropin-Releasing Hormone (GnRH) agonists like leuprolide, which reduce estrogen production and induce a temporary menopausal state to alleviate symptoms. Progestins such as norethindrone acetate and dienogest are also approved, working by suppressing ovulation and reducing menstrual flow. Additionally, combined oral contraceptives (estrogen-progestin) are commonly used to manage pain and suppress endometrial tissue growth. More recently, GnRH antagonists like elagolix have been approved, offering a different mechanism by directly inhibiting GnRH receptors to lower estrogen levels. These treatments aim to reduce endometriosis-associated pain and slow disease progression.

What other types of research exist?

Promising novel alternatives to HMI-115 for endometriosis treatment include selective inhibition of prostaglandin E2 receptors EP2 and EP4, which suppresses integrin-mediated mechanisms, and the use of ellagic acid metabolites urolithin A and B, which affect growth, adhesion, motility, and invasion of endometriotic cells. Additionally, the levonorgestrel-releasing intrauterine device (LNG-IUD) and various hormone therapies such as GnRH agonists and antagonists are also considered effective.

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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

Must not have

Subject has clinically significant gynecologic condition other than endometriosis

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 12 and 24

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious gynecological condition that is not endometriosis.

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I have had severe reactions to opioids or NSAIDs, or I can't use them due to stomach issues.

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I have or had a pituitary tumor.

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I have had a hysterectomy and/or both ovaries removed.

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I have been diagnosed with osteoporosis or another bone disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 12 and 24

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change of dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) from Baseline to Week 12

Secondary study objectives

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for endometriosis primarily involve hormonal therapies that aim to reduce or eliminate menstruation, thereby decreasing endometrial tissue growth and associated pain. Estrogen-progestin contraceptives and progestin-only therapies like dienogest work by suppressing ovulation and stabilizing endometrial tissue. GnRH agonists and antagonists reduce estrogen production by downregulating the pituitary gland, leading to a hypoestrogenic state that shrinks endometrial implants. Non-hormonal treatments, including antiangiogenic agents and immunomodulators, target the blood supply and immune response involved in endometrial tissue growth. These mechanisms are crucial for managing endometriosis symptoms, improving quality of life, and preserving fertility in patients.

Meta-Study of the Clinical Effect of Conservative Treatment in Uterine Fibroids.State of the art, new treatment strategies, and emerging drugs for non-hormonal treatment of endometriosis: a systematic review of randomized control trials.Endometriosis - insights into a multifaceted entity.