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Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist

Relugolix for Uterine Fibroids

Phase 3

Recruiting

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 baseline up to month 6, 12, 18, 24, 30, 36, and 42

Awards & highlights

Study Summary

This trial aims to understand how a 4-year treatment with a relugolix combination tablet affects bone mineral density in premenopausal women with heavy bleeding or endometriosis pain.

Who is the study for?

This trial is for premenopausal women aged 18-50 with uterine fibroids or endometriosis causing heavy menstrual bleeding or pain. Participants must not be at risk of pregnancy or agree to nonhormonal contraception for 4 years, have a BMI ≥ 18 kg/m^2, and cannot have certain bone density issues, vitamin D deficiencies without supplementation, history of specific cancers, organ transplants, psychiatric disorders affecting study participation, or use prohibited medications.Check my eligibility

What is being tested?

The trial studies the long-term effects (up to 48 months) of Relugolix Combination Tablet on bone mineral density in women with uterine fibroids or endometriosis. It includes continuous treatment and a follow-up year to monitor changes in bone health.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include those commonly associated with hormone therapies such as hot flashes, mood swings, decreased libido and possible impacts on bone density which this study aims to monitor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to month 6, 12, 18, 24, 30, 36, and 42

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to month 6, 12, 18, 24, 30, 36, and 42

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to month 6, 12, 18, 24, 30, 36, and 42 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change from baseline in BMD (bone mineral density) at Month 48 on-treatment at lumbar spine (L1-L4) in women with uterine fibroids.

Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in women with endometriosis.

Secondary outcome measures

Incidence and location of fractures during the 48 months on treatment and 12 months PTFU.

Incidence of treatment-emergent serious adverse events, and non-serious adverse events leading to treatment discontinuation or withdrawal from the study during the 48 months of treatment.

Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in the overall study population.

+12 more

Side effects data

From 2020 Phase 3 trial • 388 Patients • NCT03049735

11%

Hot flush

11%

Headache

Hypertension

Arthralgia

Upper respiratory tract infection

Avulsion fracture

Ankle fracture

Uterine myoma expulsion

Haematemesis

uterine leiomyoma

Menorrhagia

Pelvic pain

Rhabdomyolysis

Cough

Vitreous detachment

Hypothyroidism

100%

80%

60%

40%

20%

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 Combination TabletExperimental Treatment1 Intervention

Participants will receive relugolix combination therapy orally once daily for 48 months.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Myovant Sciences GmbHLead Sponsor

22 Previous Clinical Trials

11,490 Total Patients Enrolled

Sumitomo Pharma Switzerland GmbHLead Sponsor

14 Previous Clinical Trials

2,493 Total Patients Enrolled

Myovant Medical DirectorStudy DirectorMyovant Sciences GmbH

Frequently Asked Questions

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

For whom is this research endeavor most appropriate?

"The criteria for patient eligibility in this trial is endometriosis and age between 18-50. This pioneering study hopes to include 1000 participants."

Answered by AI

Is enrollment available for this experiment presently?

"The clinical study, which was initially posted on September 14th 2023, is actively searching for participants. Recent updates to the trial were recorded on Septmeber 15th of this year."

Answered by AI

How many individuals are undergoing evaluation in this clinical research?

"Affirmative, the information hosted on clinicaltrials.gov demonstrates that this trial was made available to members of the public on September 14th 2023 and has since been amended. The research is expecting 1000 participants from 25 different medical sites."

Answered by AI

Does this investigation accept participants who are 55 years or older?

"This clinical trial is open to adults between the ages of 18 and 50 years. There are several other trials for participants outside that age range, including 5 studies available to minors, as well as 37 dedicated to seniors aged 65 and over."

Answered by AI

How many sites have been designated to execute this research?

"Presently, 25 medical centres across the nation are running this trial. To name a few: Chandler, Canoga Park and Hialeah. It is advisable to select the site closest to you in order to minimize travel requirements should you decide to participate."

Answered by AI

What potential danger does the Relugolix Combination Tablet pose to users?

"According to our team at Power, the safety of Relugolix Combination Tablet was rated a 3 on a scale from 1-3 due to Phase 3 trial data that suggests efficacy as well as multiple rounds supporting its safety."

Answered by AI

What are the primary goals of this research endeavor?

"This trial, which is monitored until Month 48, aims to measure the percentage difference of bone mineral density in female endometriosis patients at lumbar spine (L1-L4) post treatment. Secondary objectives include measuring similar changes for women with uterine fibroids and endometriosis over 6, 12, 18, 24, 30 36 and 42 months after treatment according to dual-energy X-ray absorptiometry scans as well as post-treatment follow up data collection over 6 and 12 months from each group."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis

2023. "A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05862272.

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