UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014627
Receipt number 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 2021/01/27 17:00:43

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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

Obstetrics 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

Name of lead principal investigator

1st name Tomohiro
Middle name
Last name Donishi

Organization

Wakayama Medical University

Division name

Department of System Neurophysiology

Zip code

641-8509

Address

Kimiidera 811-1, Wakayama

TEL

073-441-0622

Email

tdonishi@wakayama-med.ac.jp


Public contact

Name of contact person

1st name Tomohiro
Middle name
Last name Donishi

Organization

Wakayama Medical University

Division name

Department of System Neurophysiology

Zip code

641-8509

Address

Kimiidera 811-1, Wakayama

TEL

073-441-0622

Homepage URL


Email

tdonishi@wakayama-med.ac.jp


Sponsor or person

Institute

Wakayama Medical University

Institute

Department

Personal name



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

Research Ethics Committee of Wakayama Medical University

Address

Kimiidera 811-1, Wakayama

Tel

073-447-2300

Email

wa-rinri@wakayama-med.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

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

2014 Year 07 Month 31 Day

Anticipated trial start date

2014 Year 08 Month 01 Day

Last follow-up date

2021 Year 07 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

2014 Year 07 Month 23 Day

Last modified on

2021 Year 01 Month 27 Day



Link to view the page

Value
https://center6.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