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Estrogen/Progestin Combination

Relugolix for Endometriosis

Phase 3
Waitlist Available
Research Sponsored by Myovant Sciences GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 104
Awards & highlights

Study Summary

This trial will study the long-term effects of a drug combination on endometriosis-associated pain. The drug combination consists of relugolix, estradiol, and norethindrone acetate. The trial will last 104 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104
+1 more
Secondary outcome measures
Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 104
Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 52
Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 104
+34 more

Side effects data

From 2020 Phase 3 trial • 388 Patients • NCT03049735
11%
Hot flush
11%
Headache
5%
Hypertension
3%
Arthralgia
1%
Upper respiratory tract infection
1%
Avulsion fracture
1%
Ankle fracture
1%
Uterine myoma expulsion
1%
Haematemesis
1%
uterine leiomyoma
1%
Menorrhagia
1%
Pelvic pain
1%
Rhabdomyolysis
1%
Cough
1%
Vitreous detachment
1%
Hypothyroidism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Relugolix Plus E2/NETA (Group A)
Relugolix Plus Delayed E2/NETA (Group B)
Placebo (Group C)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Relugolix plus E2/NETAExperimental Treatment2 Interventions
Relugolix co-administered with E2/NETA for 80 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Relugolix
2016
Completed Phase 3
~5360
Estradiol/norethindrone acetate
2017
Completed Phase 3
~3540

Find a Location

Who is running the clinical trial?

Myovant Sciences GmbHLead Sponsor
22 Previous Clinical Trials
11,688 Total Patients Enrolled
5 Trials studying Endometriosis
3,941 Patients Enrolled for Endometriosis
Myovant Medical MonitorStudy DirectorMyovant Sciences
9 Previous Clinical Trials
4,757 Total Patients Enrolled
2 Trials studying Endometriosis
1,261 Patients Enrolled for Endometriosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What have patients most commonly been prescribed Relugolix for in the past?

"Relugolix is an effective treatment for advanced androgen dependent prostate cancer, no menstrual period in previous 6 months, and hypoestrogenism."

Answered by AI

Are middle-aged or elderly patients being seen in this trial?

"This trial is only open to patients aged 18-51. If you are under 18, there are 13 other clinical trials you may be eligible for. If you are over 65, there are 38 other clinical trials you may be eligible for."

Answered by AI

What other medical studies have there been on Relugolix in the past?

"As of now, there are 62 ongoing studies on the efficacy of Relugolix. Out of these, 11 are in Phase 3. Moreover, Relugolix trials are not limited to Greensboro, North carolina- there are 1059 clinical trial sites for Relugolix across the globe."

Answered by AI

What have been the reported side effects of Relugolix?

"Like other Phase 3 drugs, Relugolix has undergone multiple rounds of testing to ensure its efficacy and safety. Our team at Power gave it a score of 3."

Answered by AI

Could you please tell me how many locations are conducting this trial?

"Out of the total 58 clinical trial sites, this study is recruiting patients from Shawnee Mission, Corpus Christi, Hialeah, and 55 other locations. If you enroll in this trial, it is important to choose a location near you to reduce travel."

Answered by AI

If I qualify, can I join this experiment?

"This study is open to 803 people with endometrioma between the ages of 18 and 51. To be eligible, patients must meet the following 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"

Answered by AI

Are there still open positions in this trial for participants?

"Unfortunately, this particular trial is not seeking patients at the moment. Although, it is worth noting that there are other154 trials with open recruitment at this time. This specific trial was posted on May 22nd, 2018 and was last updated on May 31st, 2022."

Answered by AI

What is the most people that can join this research project?

"Unfortunately, this study has already reached its recruitment goal and is no longer searching for new participants. If you are interested in other studies, there are 92 trials actively recruiting participants with endometrioma and 62 studies for Relugolix admitting patients."

Answered by AI

Why was this clinical trial designed the way that it was?

"The goal of this trial is to Proportion Of Women Who Respond Or Maintain Response Based On Assessment Of Dysmenorrhea At Week 52 And Week 104. Secondary outcomes include Change From Parent Study Baseline In Overall NRS Scores At Week 52 And Week 104 which is defined as Assessed using a NRS score (11-point scale) for overall pain recorded daily in an e-Diary., Change From The Parent Study Baseline In Function Due To Endometriosis-associated Pain At Week 52 And Week 104 which is defined as Assessed using the Pain Domain of the Endometriosis Health Profile (EHP)-30"

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~117 spots leftby Apr 2025