Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03744507
Registration number
NCT03744507
Ethics application status
Date submitted
13/11/2018
Date registered
16/11/2018
Date last updated
10/11/2020
Titles & IDs
Public title
Bone Mineral Density in Women With Uterine Fibroids or Endometriosis
Query!
Scientific title
A Prospective Observational Study of Bone Mineral Density in Women With Uterine Fibroids or Endometriosis
Query!
Secondary ID [1]
0
0
2018-001367-22
Query!
Secondary ID [2]
0
0
MVT-601-034
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Uterine Fibroid
0
0
Query!
Endometriosis
0
0
Query!
Condition category
Condition code
Inflammatory and Immune System
0
0
0
0
Query!
Connective tissue diseases
Query!
Cancer
0
0
0
0
Query!
Other cancer types
Query!
Reproductive Health and Childbirth
0
0
0
0
Query!
Other reproductive health and childbirth disorders
Query!
Reproductive Health and Childbirth
0
0
0
0
Query!
Menstruation and menopause
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
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.
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage change in Bone Mineral Density (BMD) in lumbar spine (L1-L4).
Query!
Assessment method [1]
0
0
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Query!
Timepoint [1]
0
0
from Baseline up to Week 52
Query!
Primary outcome [2]
0
0
Percentage change in BMD in the femoral neck and total hip.
Query!
Assessment method [2]
0
0
Assessed by DXA scan.
Query!
Timepoint [2]
0
0
from Baseline up to Week 52
Query!
Primary outcome [3]
0
0
Absolute change in BMD in the lumbar spine (L1-L4), femoral neck and total hip.
Query!
Assessment method [3]
0
0
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Query!
Timepoint [3]
0
0
from Baseline up to Week 52
Query!
Secondary outcome [1]
0
0
Healthcare utilization for uterine fibroids or endometriosis
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
over 52 weeks
Query!
Secondary outcome [2]
0
0
Frequency of concomitant medication use.
Query!
Assessment method [2]
0
0
Assessed through participants self-reporting.
Query!
Timepoint [2]
0
0
over 52 weeks
Query!
Secondary outcome [3]
0
0
Change from Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L).
Query!
Assessment method [3]
0
0
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).
Query!
Timepoint [3]
0
0
from Baseline up to Week 52
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
50
Years
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
Query!
Key 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
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
3/08/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
31/07/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
660
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Query!
Recruitment hospital [1]
0
0
Blacktown - Blacktown
Query!
Recruitment hospital [2]
0
0
Kanwal - Kanwal
Query!
Recruitment hospital [3]
0
0
Sherwood - Sherwood
Query!
Recruitment hospital [4]
0
0
Nedlands - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2148 - Blacktown
Query!
Recruitment postcode(s) [2]
0
0
2259 - Kanwal
Query!
Recruitment postcode(s) [3]
0
0
4075 - Sherwood
Query!
Recruitment postcode(s) [4]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Michigan
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
North Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Ohio
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Tennessee
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Virginia
Query!
Country [15]
0
0
Chile
Query!
State/province [15]
0
0
Santiago
Query!
Country [16]
0
0
Czechia
Query!
State/province [16]
0
0
Jihocesky KRAJ
Query!
Country [17]
0
0
Czechia
Query!
State/province [17]
0
0
Praha
Query!
Country [18]
0
0
Czechia
Query!
State/province [18]
0
0
Severomoravsky KRAJ
Query!
Country [19]
0
0
Georgia
Query!
State/province [19]
0
0
Borjomi
Query!
Country [20]
0
0
Georgia
Query!
State/province [20]
0
0
Tbilisi
Query!
Country [21]
0
0
Hungary
Query!
State/province [21]
0
0
Bacs-kiskun
Query!
Country [22]
0
0
Hungary
Query!
State/province [22]
0
0
Bekes
Query!
Country [23]
0
0
Hungary
Query!
State/province [23]
0
0
Csongrad
Query!
Country [24]
0
0
Hungary
Query!
State/province [24]
0
0
Hajdu-bihar
Query!
Country [25]
0
0
Poland
Query!
State/province [25]
0
0
Lubelskie
Query!
Country [26]
0
0
Poland
Query!
State/province [26]
0
0
Mazowieckie
Query!
Country [27]
0
0
Poland
Query!
State/province [27]
0
0
Podlaskie
Query!
Country [28]
0
0
Poland
Query!
State/province [28]
0
0
Slaskie
Query!
Country [29]
0
0
Poland
Query!
State/province [29]
0
0
Wielkopolskie
Query!
Country [30]
0
0
Poland
Query!
State/province [30]
0
0
Zachodniopomorskie
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Myovant Sciences GmbH
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to characterize the longitudinal bone mineral density (BMD) in
premenopausal women with uterine fibroids or endometriosis.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03744507
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03744507
Download to PDF