Bone Mineral Density in Women With Uterine Fibroids or Endometriosis
NCT ID: NCT03744507
Last Updated: 2020-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
660 participants
OBSERVATIONAL
2018-08-03
2020-07-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Uterine Fibroids
Premenopausal women with uterine fibroids confirmed by an ultrasound.
No interventions assigned to this group
Endometriosis
Premenopausal women with endometriosis diagnosed or confirmed by surgical or direct visualization, or histopathology within 10 years of the Screening visit.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
50 Years
FEMALE
No
Sponsors
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Myovant Sciences GmbH
INDUSTRY
Responsible Party
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Locations
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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
Miami
Miami, Florida, United States
Orange City
Orange City, Florida, United States
Orlando
Orlando, Florida, United States
Port St. Lucie
Port Saint Lucie, Florida, United States
Sarasota
Sarasota, Florida, United States
West Palm Beach
West Palm Beach, Florida, United States
Atlanta
Atlanta, Georgia, United States
Decatur
Decatur, Georgia, United States
Norcross
Norcross, Georgia, United States
Oak Brook
Oak Brook, Illinois, United States
Towson
Towson, Maryland, United States
Canton
Canton, Michigan, United States
Durham
Durham, North Carolina, United States
Raleigh
Raleigh, North Carolina, United States
Winston-Salem
Winston-Salem, North Carolina, United States
Columbus
Columbus, Ohio, United States
Chattanooga
Chattanooga, Tennessee, United States
Memphis
Memphis, Tennessee, United States
Memphis
Memphis, Tennessee, United States
Beaumont
Beaumont, Texas, United States
Fort Worth
Fort Worth, Texas, United States
Houston
Houston, Texas, United States
Houston
Houston, Texas, United States
San Antonio
San Antonio, Texas, United States
Sugar Land
Sugar Land, Texas, United States
Webster
Webster, Texas, United States
Virginia Beach
Virginia Beach, Virginia, United States
Blacktown
Blacktown, New South Wales, Australia
Kanwal
Kanwal, New South Wales, Australia
Sherwood
Sherwood, Queensland, Australia
Nedlands
Nedlands, Western Australia, Australia
Santiago
Santiago, , Chile
Santiago
Santiago, , Chile
Santiago
Santiago, , Chile
Pisek
Písek, Jihočeský kraj, Czechia
Praha 10
Prague, Prague, Czechia
Olomouc
Olomouc, Severomoravsky KRAJ, Czechia
Tbilisi
Tbilisi, Borjomi, Georgia
Tbilisi
Tbilisi, , Georgia
Gyula
Gyula, Bekes County, Hungary
Kecskemet
Kecskemét, Bács-Kiskun county, Hungary
Szeged
Szeged, Csongrád megye, Hungary
Debrecen
Debrecen, Hajdú-Bihar, Hungary
Skorzewo
Skórzewo, Greater Poland Voivodeship, Poland
Lublin
Lublin, Lublin Voivodeship, Poland
Lublin
Lublin, Lublin Voivodeship, Poland
Warszawa
Warsaw, Masovian Voivodeship, Poland
Warszawa
Warsaw, Masovian Voivodeship, Poland
Biaystok
Bialystok, Podlaskie Voivodeship, Poland
Biaystok
Bialystok, Podlaskie Voivodeship, Poland
Katowice
Katowice, Silesian Voivodeship, Poland
Katowice
Katowice, Silesian Voivodeship, Poland
Szczecin
Szczecin, West Pomeranian Voivodeship, Poland
Countries
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Other Identifiers
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2018-001367-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MVT-601-034
Identifier Type: -
Identifier Source: org_study_id