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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
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 moreSide effects data
From 2020 Phase 3 trial • 388 Patients • NCT0304973511%
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 Combination TabletExperimental Treatment1 Intervention
Participants will receive relugolix combination therapy orally once daily for 48 months.
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Who is running the clinical trial?
Myovant Sciences GmbHLead Sponsor
22 Previous Clinical Trials
11,490 Total Patients Enrolled
Sumitomo Pharma Switzerland GmbHLead Sponsor
16 Previous Clinical Trials
4,815 Total Patients Enrolled
Myovant Medical DirectorStudy DirectorMyovant Sciences GmbH
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