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

Conditions

• Endometriosis
• Uterine Fibroids

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• Relugolix Combination Tablet — DRUG
  A fixed-dose combination tablet containing relugolix 40 mg, estradiol (E2) 1 mg, and norethindrone acetate (NETA) 0.5 mg.

Study Details

The purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) or with moderate-to-severe pain associated with endometriosis.

Key Dates

Start date

Aug 14, 2023

Status verified

Jul 2025

Primary completion

Jul 31, 2029

Completion

Sep 30, 2030

Study Design

Enrollment

1,000 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Relugolix Combination Tablet
  Participants will receive relugolix combination therapy orally once daily for 48 months.

Primary Outcome Measure

Percent change from baseline in BMD (bone mineral density) at Month 48 on-treatment at lumbar spine (L1-L4) in women with uterine fibroids. [ Time Frame: Baseline up to Month 48 ]

Central Contacts

• Clinical Trials at Myovant
  650-278-8743
  [email protected]

Locations (120)

Find similar trials in Mobile, AL

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