NCT03744507

Bone Mineral Density in Women With Uterine Fibroids or Endometriosis

A Prospective Observational Study of Bone Mineral Density in Women With Uterine Fibroids or Endometriosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 660 (actual)
• Sponsor: Myovant Sciences GmbH · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: —

Summary

The purpose of this study is to characterize the longitudinal bone mineral density (BMD) in premenopausal women with uterine fibroids or endometriosis.

Detailed description

This is a prospective observational study to characterize longitudinal BMD of premenopausal women with uterine fibroids or endometriosis over the 52-week observational period. Approximately 660 participants will be recruited into two cohorts: (1) premenopausal women with uterine fibroids confirmed by an ultrasound (approximately 260 participants), and (2) premenopausal women with endometriosis diagnosed or confirmed by surgical or direct visualization, or histopathology within 10 years of the Screening visit (approximately 400 participants). Since age is a strong risk factor for BMD change over time, participants in this observational study will be matched by age category (18 to 24, 25 to 34, 35 to 44, and ≥45 years old), with participants enrolled in the interventional studies of relugolix. During the Screening/Baseline period, the participant should be assessed for eligibility, and baseline dual-energy X-ray absorptiometry (DXA) scan will be obtained. Bone densitometry (lumbar spine \[L1-L4\], total hip, and femoral neck) will be obtained and submitted for central reading at Baseline, Week 24, and Week 52. Information related to health care utilization for uterine fibroids or endometriosis and concomitant medications will be collected at every visit and during the phone calls at Week 12 and Week 36. Collection of adverse events in this study will be limited to protocol-specified procedure-related adverse events. Reports of pregnancy will also be collected.

Conditions

• Uterine Fibroid
• Endometriosis

Timeline

• Start date: 2018-08-03
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2018-11-16
• Last updated: 2020-11-10

Locations

63 sites across 7 countries: United States, Australia, Chile, Czechia, Georgia, Hungary, Poland