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

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Uterine Fibroids
• Endometriosis

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

18 to 50 years

Sex

Female

Healthy volunteers

Not accepted

Sponsor

Sumitomo Pharma Switzerland GmbH

Last updated on ClinicalTrials.gov

August 6, 2025

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites