Relugolix CT for Endometriosis

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: University of Michigan

Must not be taking: Opioids, Injectable hormones

Disqualifiers: Pregnancy, Breast cancer, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 24 weeks

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Relugolix Combination-Therapy to evaluate its effectiveness in alleviating pelvic pain in women with moderate-to-severe endometriosis-related pain. The study aims to understand the therapy's impact on pain, inflammation, and sensitivity. All participants will receive the same treatment, but the study will compare those with widespread pain to those without it. Women who have experienced moderate-to-severe pelvic pain for at least six months and have been diagnosed with endometriosis might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for endometriosis-related pain.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications before joining the trial. There is a 30-60 day period where you must stop using oral, vaginal, transdermal, or intrauterine hormonal therapies. Additionally, you need to avoid pain medications like NSAIDs and acetaminophen for 12 hours before certain tests.

Is there any evidence suggesting that Relugolix Combination-Therapy is likely to be safe for humans?

Research has shown that Relugolix Combination-Therapy (CT) is generally well-tolerated by women with endometriosis. Studies have found that this treatment can reduce pain and improve daily function over time. For up to two years, Relugolix CT effectively lessened both menstrual and non-menstrual pain, as well as pain during sex.

Importantly, the treatment maintained bone strength, indicating it does not weaken bones over time. Most patients continued with the treatment, suggesting they did not experience severe side effects. Overall, evidence suggests that Relugolix CT is safe and effectively manages pain related to endometriosis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for endometriosis, which often include hormonal therapies like birth control pills or surgery to remove excess tissue, Relugolix Combination-Therapy (CT) offers a novel approach by utilizing a combination of relugolix, estradiol, and norethindrone acetate. This treatment works differently by targeting the pituitary gland to reduce estrogen production, which can help alleviate the painful symptoms of endometriosis. Researchers are excited about Relugolix CT because it provides an oral, once-daily option that might offer effective symptom relief with fewer side effects. This combination therapy has the potential to improve the quality of life for those with endometriosis, offering a promising alternative to existing therapies.

What evidence suggests that Relugolix Combination-Therapy might be an effective treatment for endometriosis?

Research has shown that Relugolix Combination-Therapy (CT) helps relieve pain caused by endometriosis. Studies found that using Relugolix CT for up to two years greatly reduces pain during periods, outside of periods, and during sex. Besides easing pain, patients noticed improved ability to perform daily activities. Results from five clinical trials demonstrated significant pain relief for those taking Relugolix. The treatment was well-tolerated and did not harm bone health over time. Overall, Relugolix CT offers a promising option for managing pain linked to endometriosis. ^{2 3 4 6 7}

Who Is on the Research Team?

Sawsan As-Sanie, MD, MPH

Principal Investigator

University of Michigan

Andrew Schrepf, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for women with moderate-to-severe pelvic pain due to endometriosis. Participants should be eligible for hormone suppression therapy and not have conditions that would interfere with the study or pose a risk.

Inclusion Criteria

Willingness to washout interval of hormonal therapies prior to study initiation if applicable

Willing to undergo quantitative sensory testing (QST), fMRI, and other study procedures

Meet criteria to participate in QST and fMRI

Exclusion Criteria

History of substance abuse within the past one year

I have been diagnosed with vulvodynia.

I have not had psychosis or attempted suicide in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Relugolix Combination-Therapy (CT) daily for 24 weeks

24 weeks

Baseline, week 12 visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Relugolix Combination-Therapy

Trial Overview The study investigates how Relugolix Combination Therapy (CT) affects pelvic pain, inflammation, and sensitivity to pain in women suffering from endometriosis-associated pelvic pain.

How Is the Trial Designed?

Group I: Relugolix CT Experimental Treatment 1 Intervention

All participants will have the same intervention, but approximately half of those enrolled will have widespread pain and half will not. Approximately 65 participants with widespread pain will receive relugolix CT (relugolix 40mg, estradiol 1 mg, norethindrone acetate 0.5 mg once daily) daily for 24 weeks, and 65 participants without widespread pain will receive relugolix CT for 24 weeks.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38243752/

Two-year efficacy and safety of relugolix combination ... For up to 2 years, treatment with relugolix CT improved menstrual and non-menstrual pain, dyspareunia, and function in women with endometriosis.

2. academic.oup.com academic.oup.com/humrep/article/39/3/526/7577817

Two-year efficacy and safety of relugolix combination therapy ... For up to 2 years, treatment with relugolix CT improved menstrual and non-menstrual pain, dyspareunia, and function in women with endometriosis.

3. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2025.1650579/full

Relugolix's impact on endometriosis-associated pain and ... Results: Five RCTs were included. Overall, relugolix significantly improved EHP-30 Pain domain scores (MD = 6.77, 95% CI: 3.15 to 10.39, p=0.0002) but showed ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1553465021004507

Sustained Efficacy and Safety of Relugolix Combination ... Conclusion. Relugolix-CT was well tolerated and demonstrated sustained improvement of endometriosis-associated pain and maintenance of BMD through 52 weeks.

5. fertstert.org fertstert.org/article/S0015-0282(24)00540-5/fulltext

Impact of relugolix combination therapy on functioning and ... Sustained reduction of endometriosis-associated pain with relugolix CT observed up to 104 weeks was accompanied by improvements in functioning ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10905503/

Two-year efficacy and safety of relugolix combination therapy ... For up to 2 years, treatment with relugolix CT improved menstrual and non-menstrual pain, dyspareunia, and function in women with endometriosis.

7. contemporaryobgyn.net contemporaryobgyn.net/view/long-term-outcomes-of-relugolix-combination-therapy-for-severe-endometriosis

Long-term outcomes of relugolix combination therapy for ... The 104-week study involving 681 patients reveals high compliance, with 98.7% and 98.8% reporting drug compliance. Responder rates for ...