CompletedPhase 3

SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain

United States, Argentina, Australia802 participantsStarted 2018-05-22

Plain-language summary

The purpose of this study is to evaluate the long-term efficacy and safety of relugolix 40 milligram (mg) once daily co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) for up to 104 weeks on endometriosis-associated pain in participants who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or MVT-601-3102).

Who can participate

Age range

18 Years – 51 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Completed 24 weeks of study drug treatment and study participation in either parent study, MVT-601-3101 or MVT-601-3102.
. Is not expected to undergo gynecological surgery or other surgical procedures for treatment of endometriosis (including ablation, shaving, or excision) during the study, including during the Follow-Up Period, and the participant does not desire such treatment during this time frame.
. Has agreed to continue to use only study-specified analgesic medications during the study and is not known to be intolerant to these.

Exclusion criteria

. Has had a surgical procedure for treatment for endometriosis at any time during the parent study (MVT-601-3101 or MVT-601-3102).
. Has any chronic pain or frequently recurring pain condition, other than endometriosis, that is treated with opioids or requires analgesics for ≥ 7 days per month.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52

Timeframe: Week 52

Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 52

Timeframe: Week 52

Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104

Timeframe: Week 104

Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104

Timeframe: Week 104

Trial details

NCT IDNCT03654274

SponsorMyovant Sciences GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-16

Results submitted2023-03-03

View on ClinicalTrials.gov More Endometriosis trials

Plain-language summary

Who can participate

Age range

18 Years – 51 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Completed 24 weeks of study drug treatment and study participation in either parent study, MVT-601-3101 or MVT-601-3102.
. Is not expected to undergo gynecological surgery or other surgical procedures for treatment of endometriosis (including ablation, shaving, or excision) during the study, including during the Follow-Up Period, and the participant does not desire such treatment during this time frame.
. Has agreed to continue to use only study-specified analgesic medications during the study and is not known to be intolerant to these.

Exclusion criteria

. Has had a surgical procedure for treatment for endometriosis at any time during the parent study (MVT-601-3101 or MVT-601-3102).
. Has any chronic pain or frequently recurring pain condition, other than endometriosis, that is treated with opioids or requires analgesics for ≥ 7 days per month.

What they're measuring

Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52

Timeframe: Week 52

Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 52

Timeframe: Week 52

Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104

Timeframe: Week 104

Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104

Timeframe: Week 104