UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038120 |
|---|---|
| Receipt number | R000043444 |
| Scientific Title | The effects of the menstrual cycle on performance factors in the athletes of woman |
| Date of disclosure of the study information | 2019/09/28 |
| Last modified on | 2019/09/26 19:53:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effects of the menstrual cycle on performance factors in the athletes of woman
Acronym
The effects of the menstrual cycle on performance factors in the athletes of woman
Scientific Title
The effects of the menstrual cycle on performance factors in the athletes of woman
Scientific Title:Acronym
The effects of the menstrual cycle on performance factors in the athletes of woman
Region
| Japan |
Condition
Condition
non-acute patients of the rehabilitation
Classification by specialty
| Obstetrics and Gynecology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the influence between the menstrual cycle and the performance
Basic objectives2
Others
Basic objectives -Others
The finding of the factors which is related to higer performance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the physical functional changement of the women athelete by menstrual cycle and the level of the female hormone
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
blood collection
Once in menstruation, ovulation, luteal phase
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
| Not applicable |
Gender
Female
Key inclusion criteria
The patient who does not acute disease and take the rehabilitation
The age is above 20 years olds to premenopausal
Key exclusion criteria
The patients who takes the hormonal medicine
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | KAMADA |
Organization
University of Tsukuba / University of Tsukuba Hospital
Division name
Department of Orthopaedic Surgery
Zip code
3058576
Address
1-1-1 Tennodai Tsukuba
TEL
+81-29-853-3219
hkamada@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Sari |
| Middle name | |
| Last name | NAKAO |
Organization
University of Tsukuba / University of Tsukuba Hospital
Division name
Department of Obstetrics & Gynecology
Zip code
3058576
Address
1-1-1 Tennodai Tsukuba
TEL
+81-853-3073
Homepage URL
s.nakao@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba Hospital
Department of Obstetrics & Gynecology
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
Tsukuba Sports Medicine & Health Science Center
Address
1-1-1 Tennodai Tsukuba
Tel
029-853-3910
nothing
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
| 2019 | Year | 09 | Month | 28 | 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
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
Preinitiation
Date of protocol fixation
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 26 | Day |
Last modified on
| 2019 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043444
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
