UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058091 |
|---|---|
| Receipt number | R000066369 |
| Scientific Title | Effects of sex, menstrual cycle, and exercise training on cutaneous vasodilation in females and the mechanisms |
| Date of disclosure of the study information | 2025/06/12 |
| Last modified on | 2025/06/12 10:44:49 |
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Basic information
Public title
Effects of sex, menstrual cycle, and exercise training on cutaneous vasodilation in females and the mechanisms
Acronym
Effects of sex, menstrual cycle, and exercise training on cutaneous vasodilation in females and the mechanisms
Scientific Title
Effects of sex, menstrual cycle, and exercise training on cutaneous vasodilation in females and the mechanisms
Scientific Title:Acronym
Effects of sex, menstrual cycle, and exercise training on cutaneous vasodilation in females and the mechanisms
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare cutaneous vascular function and the mechanism of cutaneous vasodilation involving nitric oxide synthase between males and females, menstrual phases, and with and without exercise habits.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cutaneous vascular conductance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Application of a nitric oxide synthase inhibitor (2% L-NAME) using transdermal iontophoresis or intradermal microdialysis
Interventions/Control_2
Application of saline using transdermal iontophoresis or intradermal microdialysis
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy males and females between the ages of 18 and 40
Key exclusion criteria
1) Smoker, obese individuals
2) Individuals experienced any cardiovascular disease
3) Individuals with cardiac arrhythmia
4) Individuals with asthma
5) Individuals with gastrointestinal disease
6) Individuals with epilepsy
7) Individuals taking any medications drugs
8) Individuals experienced fainting during blood sampling
9) Individuals who have been considered to exclude the participants based on a researcher
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Okamoto |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Health Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
TEL
025-257-4590
yumi-okamoto@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Okamoto |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Health Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
TEL
025-257-4590
Homepage URL
yumi-okamoto@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Yumi Okamoto
Funding Source
Organization
JSPS
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
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
Tel
025-257-4455
rinri@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
| 2025 | Year | 06 | Month | 12 | 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
| 2025 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | 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
| 2025 | Year | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066369
