UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046405 |
|---|---|
| Receipt number | R000052910 |
| Scientific Title | Single center retrospective observational study of telemedicine in prescribing LEP (low dose pills) for dysmenorrhea patients |
| Date of disclosure of the study information | 2021/12/21 |
| Last modified on | 2024/01/31 23:59:26 |
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Basic information
Public title
Study of telemedicine in prescribing low dose pills for dysmenorrhea patients
Acronym
Study of telemedicine in prescribing low dose pills
Scientific Title
Single center retrospective observational study of telemedicine in prescribing LEP (low dose pills) for dysmenorrhea patients
Scientific Title:Acronym
Single center retrospective observational study of telemedicine in prescribing LEP for dysmenorrhea patients
Region
| Japan |
Condition
Condition
dysmenorrhea
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm that using telemedicine when prescribing LEP does not increase disadvantage compared to using only face to face medical treatment.
Basic objectives2
Others
Basic objectives -Others
Investigation of Medical treatment form
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Probability of abnormal uterine bleeding in 6 months after the start of treatment
Key secondary outcomes
Other side effects
Continuation rate for treatment
Cost burden of patient
Treatment effectivity
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
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
Common to Both Group
1)Patients with dysmenorrhea whose target period includes the start of LEP and 6 months after the start
Telemedicine Group
1)Patients who have had at least one telemedicine within 6 months after the start of LEP
In-person care Group
1)Patients who have never had telemedicine and only have had in-person care within 6 months after the start of LEP
Key exclusion criteria
Common to Both Group
1)Patients who reject to be included this study
2)One or more LEP prescription contraindications are applicable at the start of prescription
In-person care Group
1)Patients who start LEP prescription after the telemedicine system introduction
Target sample size
212
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Iida |
Organization
Yokohama City University School of Medicine
Division name
Department of Medial Education
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Kanagawa
TEL
045-787-2627
hiro0905@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Inoo |
Organization
Yokohama City University School of Medicine
Division name
Department of Medial Education
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Kanagawa
TEL
045-787-2627
Homepage URL
inoo.yum.dk@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University School of Medicine Department of Medical Education
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
of Yokohama City University Life Science and Medical Research Ethics Committee for Humans
Address
236-0004 3-9, Fukuura, Kanazawa-ku, Kanagawa
Tel
045-370-7627
rinri@yokohama-cu.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
【既存試料・情報の提供のみを行う機関】
・医療法人社団 昱樹会 磯子悠レディースクリニック
・医療法人社団 都筑会 つづきレディスクリニック
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
172
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 | 10 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective non-inferiority observational study of a group that combines telemedicine and in-person care with respect to a group that uses only in-person care.
Management information
Registered date
| 2021 | Year | 12 | Month | 17 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052910
