UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060901 |
|---|---|
| Receipt number | R000069422 |
| Scientific Title | Effects of Menstrual Cycle-Related Sex Hormone Fluctuations on Joint Laxity and Structural Properties |
| Date of disclosure of the study information | 2026/03/11 |
| Last modified on | 2026/03/11 22:55:35 |
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Basic information
Public title
Effects of Menstrual Cycle-Related Sex Hormone Fluctuations on Joint Laxity and Structural Properties
Acronym
Effects of Menstrual Cycle-Related Sex Hormone Fluctuations on Joint Laxity and Structural Properties
Scientific Title
Effects of Menstrual Cycle-Related Sex Hormone Fluctuations on Joint Laxity and Structural Properties
Scientific Title:Acronym
Effects of Menstrual Cycle-Related Sex Hormone Fluctuations on Joint Laxity and Structural Properties
Region
| Japan |
Condition
Condition
healthy adult women
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of menstrual cycle phases and fluctuations in sex hormone concentrations on local joint laxity (elbow joint and foot) and joint deformity in healthy adult women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sixty healthy adult women will be recruited as participants. For 1 month prior to the start of the experiment, participants will be asked to monitor their menstrual cycles by recording their basal body temperature each morning, identifying the day of ovulation using an ovulation predictor kit, and documenting the duration of menstruation.
To evaluate menstrual cycle-related variations, joint stability, and sex hormone concentrations will be assessed at two time points: the early follicular phase and the ovulatory phase. Joint stability will be evaluated using an ultrasound imaging system in accordance with previous studies. For both the elbow joint and the foot, joint space distance will be measured under standardized mechanical loading conditions using a dedicated stress loading device.
In addition, saliva samples will be collected using saliva collection kits, and salivary concentrations of sex hormones (estradiol and progesterone) will be analyzed. Foot morphology, including the hallux valgus angle, fifth toe varus angle, and medial longitudinal arch height, will be measured using a three-dimensional automatic foot scanner under two loading conditions (weight-bearing [seated and standing] and non-weight-bearing). Furthermore, the carrying angle of the elbow joint will be measured using a goniometer. These alignment measurements will be performed only once.
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
Self control
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
To evaluate menstrual cycle-related variations, joint stability, and sex hormone concentrations, assessments will be conducted at two time points: the early follicular phase and the ovulatory phase. Joint stability will be evaluated using an ultrasound imaging system according to the method described in a previous study. For the elbow and foot joints, joint space distance will be measured under a standardized mechanical load using a dedicated stress device.
In addition, saliva samples will be collected using saliva collection kits, and salivary sex hormone concentrations will be measured.
Foot morphology will be assessed using a three-dimensional foot scanning system. The hallux valgus angle, fifth-toe varus angle, and medial longitudinal arch height will be measured under two conditions: weight-bearing and non-weight-bearing. Furthermore, the carrying angle of the elbow joint will be measured using a goniometer. These alignment measurements will be performed once.
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
| 18 | years-old | <= |
Age-upper limit
| 24 | years-old | >= |
Gender
Female
Key inclusion criteria
women with normal menstrual cycles
Key exclusion criteria
women with menstrual irregularities or amenorrhea
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Mutsuaki |
| Middle name | |
| Last name | Edama |
Organization
Niigata Univercity health and welfare
Division name
Depeartment of physical therapy
Zip code
950-3198
Address
Niigata, Shimami-cho 1398, Kita-ku, Niigata City
TEL
09071547408
edama@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Mutsuaki |
| Middle name | |
| Last name | Edama |
Organization
Niigata University of Health and Welfare
Division name
Depeartment of physical therapy
Zip code
950-3198
Address
Niigata, Shimami-cho 1398, Kita-ku, Niigata City
TEL
09071547408
Homepage URL
edama@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
Niigata, Shimami-cho 1398, Kita-ku, Niigata City
Tel
0252574455
edama@nuhw.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
| 2026 | Year | 03 | Month | 11 | 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
| 2026 | Year | 01 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 03 | Month | 11 | Day |
Last modified on
| 2026 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069422
