Bone Mineral Density in Women With Uterine Fibroids or Endometriosis

Completed

• Conditions: Uterine Fibroid; Endometriosis

• Registration Number: NCT03744507
• Lead Sponsor: Myovant Sciences GmbH

Brief 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.

Study Timeline

• Study Start: 2018-08-03
• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-13
• Study First Posted: 2018-11-16
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 660

Inclusion Criteria

1. Is a premenopausal female 18 to 50 years old

2. By the participant's report, had two consecutive regular menstrual cycles immediately prior to enrollment in the study. Participants with hormonal intrauterine devices or on other hormonal contraception methods that disrupt cyclic bleeding are not required to have two consecutive regular menstrual cycles.

3. Has one of the following conditions:

   1. Diagnosis of uterine fibroids that is confirmed by an ultrasound within 5 years prior to screening.
   2. Diagnosis of endometriosis confirmed by surgical or direct visualization and/or histopathologic confirmation.

4. Has not and is not expected to undergo a surgical procedure with bilateral oophorectomy within the 12 months following enrollment.

Exclusion Criteria

5. Has a weight that exceeds the weight limit of the dual-energy X-ray absorptiometry scanner
6. Has a baseline BMD z-score < -2.0 at spine, total hip, or femoral neck
7. Has a history of or currently has osteoporosis, or other metabolic bone disease
8. Use within the past 3 months prior to Screening or anticipated use of systemic glucocorticoids
9. Is currently pregnant or lactating, or intends to become pregnant during the study period

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage change in BMD in the femoral neck and total hip.	from Baseline up to Week 52	Assessed by DXA scan.
Absolute change in BMD in the lumbar spine (L1-L4), femoral neck and total hip.	from Baseline up to Week 52	Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Percentage change in Bone Mineral Density (BMD) in lumbar spine (L1-L4).	from Baseline up to Week 52	Assessed by dual-energy X-ray absorptiometry (DXA) scan.

Secondary Outcome Measures

Name	Time	Method
Healthcare utilization for uterine fibroids or endometriosis	over 52 weeks	Assessed through participants self-reporting (may be aided by review of participant medical records). Healthcare utilization includes visits to gynecologists or other primary care providers, visits to urgent care, visits to emergency department, hospitalizations, procedures (diagnostic or surgical) or changes to medication concomitant related to uterine fibroids or endometriosis.
Frequency of concomitant medication use.	over 52 weeks	Assessed through participants self-reporting.
Change from Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L).	from Baseline up to Week 52	Assessed using participants responses on the EQ-5D-5L questionnaire. The EQ-5D-5L is a standardized measure of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses (from 1= no problem to 5= extreme problems).

Trial Locations

Locations (54)

Mobile; 🇺🇸 Mobile, Alabama, United States

Mesa; 🇺🇸 Mesa, Arizona, United States

Huntington Beach; 🇺🇸 Huntington Beach, California, United States

Palos Verdes Estates; 🇺🇸 Palos Verdes Estates, California, United States

Denver; 🇺🇸 Denver, Colorado, United States

United States, Colorado; 🇺🇸 Denver, Colorado, United States

Aventura; 🇺🇸 Aventura, Florida, United States

Jupiter; 🇺🇸 Jupiter, Florida, United States

Loxahatchee; 🇺🇸 Loxahatchee Groves, Florida, United States

Margate; 🇺🇸 Margate, Florida, United States

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