Bone Mineral Density in Women With Uterine Fibroids or Endometriosis

November 6, 2020 updated by: Myovant Sciences GmbH

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

660

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Blacktown
      • Kanwal, New South Wales, Australia, 2259
        • Kanwal
    • Queensland
      • Sherwood, Queensland, Australia, 4075
        • Sherwood
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Nedlands
  • Chile
      • Santiago, Chile, 7510186
        • Santiago
      • Santiago, Chile, 8320165
        • Santiago
      • Santiago, Chile, 8360160
        • Santiago
  • Czechia
    • Jihocesky KRAJ
      • Pisek, Jihocesky KRAJ, Czechia, 39701
        • Pisek
    • Praha
      • Praha 10, Praha, Czechia, 10034
        • Praha 10
    • Severomoravsky KRAJ
      • Olomouc, Severomoravsky KRAJ, Czechia, 772 00
        • Olomouc
  • Georgia
      • Tbilisi, Georgia, 159
        • Tbilisi
    • Borjomi
      • Tbilisi, Borjomi, Georgia, 159
        • Tbilisi
  • Hungary
    • Bacs-kiskun
      • Kecskemet, Bacs-kiskun, Hungary, 6000
        • Kecskemét
    • Bekes
      • Gyula, Bekes, Hungary, 5700
        • Gyula
    • Csongrad
      • Szeged, Csongrad, Hungary, 6725
        • Szeged
    • Hajdu-bihar
      • Debrecen, Hajdu-bihar, Hungary, 4024
        • Debrecen
  • Poland
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20064
        • Lublin
      • Lublin, Lubelskie, Poland, 20093
        • Lublin
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 2066
        • Warszawa
      • Warszawa, Mazowieckie, Poland, 2929
        • Warszawa
    • Podlaskie
      • Białystok, Podlaskie, Poland, 15224
        • Biaystok
      • Białystok, Podlaskie, Poland, 15464
        • Biaystok
    • Slaskie
      • Katowice, Slaskie, Poland, 40081
        • Katowice
      • Katowice, Slaskie, Poland, 40301
        • Katowice
    • Wielkopolskie
      • Skorzewo, Wielkopolskie, Poland, 60185
        • Skórzewo
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 71434
        • Szczecin
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Mobile
    • Arizona
      • Mesa, Arizona, United States, 85215
        • Mesa
    • California
      • Huntington Beach, California, United States, 92647
        • Huntington Beach
      • Palos Verdes Estates, California, United States, 90274
        • Palos Verdes Estates
    • Colorado
      • Denver, Colorado, United States, 80209
        • Denver
      • Denver, Colorado, United States, 80211
        • United States, Colorado
    • Florida
      • Aventura, Florida, United States, 33180
        • Aventura
      • Jupiter, Florida, United States, 33458
        • Jupiter
      • Loxahatchee Groves, Florida, United States, 33470
        • Loxahatchee
      • Margate, Florida, United States, 33063
        • Margate
      • Miami, Florida, United States, 33126
        • Miami
      • Orange City, Florida, United States, 32763
        • Orange City
      • Orlando, Florida, United States, 32835
        • Orlando
      • Port Saint Lucie, Florida, United States, 34952
        • Port St. Lucie
      • Sarasota, Florida, United States, 34239
        • Sarasota
      • West Palm Beach, Florida, United States, 33409
        • West Palm Beach
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Atlanta
      • Decatur, Georgia, United States, 30034
        • Decatur
      • Norcross, Georgia, United States, 30093
        • Norcross
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • Oak brook
    • Maryland
      • Towson, Maryland, United States, 21204
        • Towson
    • Michigan
      • Canton, Michigan, United States, 48187
        • Canton
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Durham
      • Raleigh, North Carolina, United States, 27607
        • Raleigh
      • Winston-Salem, North Carolina, United States, 27103
        • Winston-Salem
    • Ohio
      • Columbus, Ohio, United States, 43231
        • Columbus
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga
      • Memphis, Tennessee, United States, 38120
        • Memphis
      • Memphis, Tennessee, United States, 38119
        • Memphis
    • Texas
      • Beaumont, Texas, United States, 77702
        • Beaumont
      • Fort Worth, Texas, United States, 76104
        • Fort Worth
      • Houston, Texas, United States, 77030
        • Houston
      • Houston, Texas, United States, 77054
        • Houston
      • San Antonio, Texas, United States, 78258
        • San Antonio
      • Sugar Land, Texas, United States, 77479
        • Sugar Land
      • Webster, Texas, United States, 77598
        • Webster
    • Virginia
      • Virginia Beach, Virginia, United States, 23456
        • Virginia Beach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women with endometriosis or with uterine fibroids

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Uterine Fibroids
Premenopausal women with uterine fibroids confirmed by an ultrasound.
Endometriosis
Premenopausal women with endometriosis diagnosed or confirmed by surgical or direct visualization, or histopathology within 10 years of the Screening visit.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare utilization for uterine fibroids or endometriosis
Time Frame: 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.
over 52 weeks
Frequency of concomitant medication use.
Time Frame: over 52 weeks
Assessed through participants self-reporting.
over 52 weeks
Change from Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L).
Time Frame: 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).
from Baseline up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myovant Sciences GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2018

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

November 13, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MVT-601-034
  • 2018-001367-22 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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