Uterine FibroidNCT03744507
Bone Mineral Density in Women With Uterine Fibroids or Endometriosis
An observational study of Uterine Fibroid and Endometriosis, run by Myovant Sciences GmbH at 63 sites in 7 countries.
Trial summary
The purpose of this study is to characterize the longitudinal bone mineral density (BMD) in premenopausal women with uterine fibroids or endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Uterine Fibroid, Endometriosis
- How many people
- 660 participants
- Where
- 63 sitesin 7 countries
- Study dates
- 3 Aug 2018to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Adult
Study population: Women with endometriosis or with uterine fibroids
Who may be able to join
- Is a premenopausal female 18 to 50 years old
- 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.
- Has one of the following conditions:
- Diagnosis of uterine fibroids that is confirmed by an ultrasound within 5 years prior to screening.
- Diagnosis of endometriosis confirmed by surgical or direct visualization and/or histopathologic confirmation.
- Has not and is not expected to undergo a surgical procedure with bilateral oophorectomy within the 12 months following enrollment.
Who cannot join
- Has a weight that exceeds the weight limit of the dual-energy X-ray absorptiometry scanner
- Has a baseline BMD z-score < -2.0 at spine, total hip, or femoral neck
- Has a history of or currently has osteoporosis, or other metabolic bone disease
- Use within the past 3 months prior to Screening or anticipated use of systemic glucocorticoids
- Is currently pregnant or lactating, or intends to become pregnant during the study period
Trial locations and contacts
63 sites in 7 countries.
63 sites in 7 countries
United States37 sites
Atlanta
Atlanta, Georgia, 30328
Aventura
Aventura, Florida, 33180
Beaumont
Beaumont, Texas, 77702
Canton
Canton, Michigan, 48187
Chattanooga
Chattanooga, Tennessee, 37404
Columbus
Columbus, Ohio, 43231
Decatur
Decatur, Georgia, 30034
Denver
Denver, Colorado, 80209
United States, Colorado
Denver, Colorado, 80211
Durham
Durham, North Carolina, 27713
Fort Worth
Fort Worth, Texas, 76104
Houston
Houston, Texas, 77030
Houston
Houston, Texas, 77054
Huntington Beach
Huntington Beach, California, 92647
Jupiter
Jupiter, Florida, 33458
Loxahatchee
Loxahatchee Groves, Florida, 33470
Margate
Margate, Florida, 33063
Memphis
Memphis, Tennessee, 38119
Memphis
Memphis, Tennessee, 38120
Mesa
Mesa, Arizona, 85215
Miami
Miami, Florida, 33126
Mobile
Mobile, Alabama, 36608
Norcross
Norcross, Georgia, 30093
Oak Brook
Oak Brook, Illinois, 60523
Orange City
Orange City, Florida, 32763
Orlando
Orlando, Florida, 32835
Palos Verdes Estates
Palos Verdes Estates, California, 90274
Port St. Lucie
Port Saint Lucie, Florida, 34952
Raleigh
Raleigh, North Carolina, 27607
San Antonio
San Antonio, Texas, 78258
Sarasota
Sarasota, Florida, 34239
Sugar Land
Sugar Land, Texas, 77479
Towson
Towson, Maryland, 21204
Virginia Beach
Virginia Beach, Virginia, 23456
Webster
Webster, Texas, 77598
West Palm Beach
West Palm Beach, Florida, 33409
Winston-Salem
Winston-Salem, North Carolina, 27103
Poland10 sites
Biaystok
Bialystok, Podlaskie Voivodeship, 15224
Biaystok
Bialystok, Podlaskie Voivodeship, 15464
Katowice
Katowice, Silesian Voivodeship, 40081
Katowice
Katowice, Silesian Voivodeship, 40301
Lublin
Lublin, Lublin Voivodeship, 20064
Lublin
Lublin, Lublin Voivodeship, 20093
Skorzewo
Skórzewo, Greater Poland Voivodeship, 60185
Szczecin
Szczecin, West Pomeranian Voivodeship, 71434
Warszawa
Warsaw, Masovian Voivodeship, 2066
Warszawa
Warsaw, Masovian Voivodeship, 2929
Australia4 sites
Blacktown
Blacktown, New South Wales, 2148
Kanwal
Kanwal, New South Wales, 2259
Nedlands
Nedlands, Western Australia, 6009
Sherwood
Sherwood, Queensland, 4075
Hungary4 sites
Debrecen
Debrecen, Hajdú-Bihar, 4024
Gyula
Gyula, Bekes County, 5700
Kecskemet
Kecskemét, Bács-Kiskun county, 6000
Szeged
Szeged, Csongrád megye, 6725
Chile3 sites
Santiago
Santiago, 7510186
Santiago
Santiago, 8320165
Santiago
Santiago, 8360160
Czechia3 sites
Olomouc
Olomouc, Severomoravsky KRAJ, 772 00
Pisek
Písek, South Bohemian Region, 39701
Praha 10
Prague, Prague, 10034
About this study
Official title: 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.
Read the 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
- Keywords
- Uterine leiomyoma, Uterine fibroids, Heavy menstrual bleeding, Menorrhagia, Endometriosis
- Medical subject headings
- Leiomyoma, Endometriosis, Myofibroma, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in Bone Mineral Density (BMD) in lumbar spine (L1-L4).
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Measured: from Baseline up to Week 52
Percentage change in BMD in the femoral neck and total hip.
Assessed by DXA scan.
Measured: from Baseline up to Week 52
Absolute change in BMD in the lumbar spine (L1-L4), femoral neck and total hip.
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Measured: from Baseline up to Week 52
Secondary outcomes (3)
Healthcare utilization for uterine fibroids or endometriosis
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.
Measured: over 52 weeks
Frequency of concomitant medication use.
Assessed through participants self-reporting.
Measured: over 52 weeks
Change from Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L).
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).
Measured: from Baseline up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start3 Aug 2018
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myovant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744507
- Sponsor's protocol ID
- MVT-601-034
- Other IDs
- 2018-001367-22, 2018
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2018
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Bone Mineral Density in Women With Uterine Fibroids or Endometriosis
- ClinicalTrials.gov ID
- NCT03744507
- Acronym / sponsor ID
- MVT-601-034
- Conditions
- Uterine Fibroid, Endometriosis
- Keywords
- Uterine leiomyoma, Uterine fibroids, Heavy menstrual bleeding, Menorrhagia, Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Myovant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women with endometriosis or with uterine fibroids
Key inclusion criteria (6 listed)
- Is a premenopausal female 18 to 50 years old
- 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.
- Has one of the following conditions:
- Has not and is not expected to undergo a surgical procedure with bilateral oophorectomy within the 12 months following enrollment.
Key exclusion criteria (5 listed)
- Has a weight that exceeds the weight limit of the dual-energy X-ray absorptiometry scanner
- Has a baseline BMD z-score < -2.0 at spine, total hip, or femoral neck
- Has a history of or currently has osteoporosis, or other metabolic bone disease
- Use within the past 3 months prior to Screening or anticipated use of systemic glucocorticoids
- Is currently pregnant or lactating, or intends to become pregnant during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Percentage change in BMD in the femoral neck and total hip.
Time frame: 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.
Time frame: from Baseline up to Week 52
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
3 secondary outcomes
Healthcare utilization for uterine fibroids or endometriosis
Time frame: over 52 weeks
Frequency of concomitant medication use.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
63 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroid and Endometriosis, run by Myovant Sciences GmbH at 63 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Poland, Australia, Hungary, Chile and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in Bone Mineral Density (BMD) in lumbar spine (L1-L4). (time frame: from Baseline up to Week 52). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.