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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014627
Receipt No. R000017012
Scientific Title Effects of sex hormones on brain activity of adult females
Date of disclosure of the study information 2014/08/01
Last modified on 2017/02/06

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Basic information
Public title Effects of sex hormones on brain activity of adult females
Acronym Effects of sex hormones on brain activity of adult females
Scientific Title Effects of sex hormones on brain activity of adult females
Scientific Title:Acronym Effects of sex hormones on brain activity of adult females
Region
Japan

Condition
Condition premenstrual syndrome
Classification by specialty
Obsterics and gynecology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to examine neural basis of effects of menstrual cycle on brain activity
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes correlations of brain activity and psychological scores with sex hormone level
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 Prevention
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 acquisition of functional MRI (30 min x 2)
blood sample (2.5 ml of serum x 2)
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
22 years-old >=
Gender Female
Key inclusion criteria healthy volunteers
Key exclusion criteria pregnancy
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tomohiro Donishi
Organization Wakayama Medical University
Division name Department of System Neurophysiology
Zip code
Address Kimiidera 811-1, Wakayama
TEL 073-441-0622
Email tdonishi@wakayama-med.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tomohiro Donishi
Organization Wakayama Medical University
Division name Department of System Neurophysiology
Zip code
Address Kimiidera 811-1, Wakayama
TEL 073-441-0622
Homepage URL
Email tdonishi@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 08 Month 01 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 Enrolling by invitation
Date of protocol fixation
2014 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 23 Day
Last modified on
2017 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017012

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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