Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Prospective Observational Study of Bone Mineral Density in Women With Uterine Fibroids or Endometriosis
Secondary ID [1] 0 0
2018-001367-22
Secondary ID [2] 0 0
MVT-601-034
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterine Fibroid 0 0
Endometriosis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Cancer 0 0 0 0
Other cancer types
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage change in Bone Mineral Density (BMD) in lumbar spine (L1-L4).
Timepoint [1] 0 0
from Baseline up to Week 52
Primary outcome [2] 0 0
Percentage change in BMD in the femoral neck and total hip.
Timepoint [2] 0 0
from Baseline up to Week 52
Primary outcome [3] 0 0
Absolute change in BMD in the lumbar spine (L1-L4), femoral neck and total hip.
Timepoint [3] 0 0
from Baseline up to Week 52
Secondary outcome [1] 0 0
Healthcare utilization for uterine fibroids or endometriosis
Timepoint [1] 0 0
over 52 weeks
Secondary outcome [2] 0 0
Frequency of concomitant medication use.
Timepoint [2] 0 0
over 52 weeks
Secondary outcome [3] 0 0
Change from Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L).
Timepoint [3] 0 0
from Baseline up to Week 52

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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2020
Sample size
Target
Accrual to date
Final
660
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Blacktown - Blacktown
Recruitment hospital [2] 0 0
Kanwal - Kanwal
Recruitment hospital [3] 0 0
Sherwood - Sherwood
Recruitment hospital [4] 0 0
Nedlands - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2259 - Kanwal
Recruitment postcode(s) [3] 0 0
4075 - Sherwood
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Chile
State/province [15] 0 0
Santiago
Country [16] 0 0
Czechia
State/province [16] 0 0
Jihocesky KRAJ
Country [17] 0 0
Czechia
State/province [17] 0 0
Praha
Country [18] 0 0
Czechia
State/province [18] 0 0
Severomoravsky KRAJ
Country [19] 0 0
Georgia
State/province [19] 0 0
Borjomi
Country [20] 0 0
Georgia
State/province [20] 0 0
Tbilisi
Country [21] 0 0
Hungary
State/province [21] 0 0
Bacs-kiskun
Country [22] 0 0
Hungary
State/province [22] 0 0
Bekes
Country [23] 0 0
Hungary
State/province [23] 0 0
Csongrad
Country [24] 0 0
Hungary
State/province [24] 0 0
Hajdu-bihar
Country [25] 0 0
Poland
State/province [25] 0 0
Lubelskie
Country [26] 0 0
Poland
State/province [26] 0 0
Mazowieckie
Country [27] 0 0
Poland
State/province [27] 0 0
Podlaskie
Country [28] 0 0
Poland
State/province [28] 0 0
Slaskie
Country [29] 0 0
Poland
State/province [29] 0 0
Wielkopolskie
Country [30] 0 0
Poland
State/province [30] 0 0
Zachodniopomorskie

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Myovant Sciences GmbH
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03744507
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03744507