What the trial was testing
The SPIRIT 1 enrolled 638 patients with endometriosis. The study was sponsored by Myovant Sciences and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
~75% had a meaningful drop in period pain at 24 weeks.
The Lancet · 2022 · NCT03204318
These findings — that had a meaningful drop in period pain on relugolix combination at 24 weeks — were published in the The Lancet and represent the headline result of the study.
Researchers tracked outcomes across 638 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with endometriosis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Relugolix combination therapy (Myfembree) is FDA-approved for moderate-to-severe endometriosis pain in pre-menopausal women and available now. It is a once-daily pill — no injections. Treatment is generally limited to two years because of bone-density concerns. Ask your gynecologist whether it is right for you.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open endometriosis trials
Impact of Pelvic Pain Podcast
The purpose of this research study is to study the impact of an educational podcast on pelvic pain. If you decide to take part in this research, you may receive the standard treatment for pelvic pain, or you may receive the standard treatment plus access to an educational podcast series. You will be randomly assigned to receive access to the podcast or to receive standard care. If you are assigned to receive access to the podcast, participating in this research will involve listening to a podcast series. All participants will complete three ten-minute online surveys over the course of 6 months. Reasons you may choose to participate in this research are if you want to learn more about pelvic pain and possible benefits of listening to the podcast, such as improved quality of life, reduced stigma, or increased satisfaction with your medical care.
Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain
The study evaluates the effect of TENS (transcutaneous electrical nerve stimulation) as add-on treatment compared with conventional analgesic treatment in patients with endometriosis-related chronic pain. Patients with frequent pain and high pain intensity will be randomized to additional treatment with TENS or conventional treatment for 8 weeks to evaluate the acute effects of TENS treatment (n=40). Patients with endometriosis-related pain that is not frequent or without high pain intensity constitute an external control group. All patients in the study will receive TENS treatment for a total of 16 weeks, for evaluation of long-term effects of TENS treatment.