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

Pivotal Trial

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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.

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