UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044776 |
|---|---|
| Receipt number | R000051141 |
| Scientific Title | WEB survey of QOL about uterine fibroids |
| Date of disclosure of the study information | 2021/07/07 |
| Last modified on | 2024/07/08 10:16:02 |
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Basic information
Public title
WEB survey of QOL about uterine fibroids
Acronym
WEB survey of QOL about uterine fibroids
Scientific Title
WEB survey of QOL about uterine fibroids
Scientific Title:Acronym
WEB survey of QOL about uterine fibroids
Region
| Japan |
Condition
Condition
None (adult female)
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of uterine fibroid diagnosis and treatment on QOL as well as work productivity.
Basic objectives2
Others
Basic objectives -Others
Internet usage questionnaire survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of QOL among the differences in medical consultation, diagnosis, and treatment status for UF.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
Females aged 20 to 49 years-old.
Key exclusion criteria
-
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Koga |
Organization
The University of Tokyo
Division name
Department of Obstetrics and Gynecology
Zip code
113-8655
Address
7-3-1 Hongo Bunkyo-ku Tokyo, 113-8655 Japan
TEL
03-3815-5411
kawotan@me.com
Public contact
Name of contact person
| 1st name | Motoko |
| Middle name | |
| Last name | Fukui |
Organization
ASKA Pharmaceutical Co., Ltd.
Division name
MEDICAL AFFAIRS Department
Zip code
108-8532
Address
2-5-1 Shibaura minato-ku Tokyo,108-8532 Japan
TEL
03-5484-8324
Homepage URL
aska-ma@aska-pharma.co.jp
Sponsor or person
Institute
ASKA Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku University Graduate School of Medecine
Macromill Carenet Inc.
Centan Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the University of Tokyo
Address
Office for Human Research Studies (OHRS), Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Faculty of Medicine Bldg.2 4F 7-3-1
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
4120
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 07 | Month | 06 | Day |
Last modified on
| 2024 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051141
