UMIN-CTR Clinical Trial

Basic information
Public title	Development of new sanitary products based on the survey of gynecologic patients
Acronym	Development of new sanitary products
Scientific Title	Development of new sanitary products
Scientific Title:Acronym	Development of new sanitary products
Region	Japan

Condition
Condition	vulvovaginal diseases
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analyze the presence or absence of vulvovaginal diseases and the relationship between vulvovaginal conditions and the symptoms and feelings of the individual, and develop hygiene products that can be alleviated according to vulvovaginal diseases and other conditions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Step 1 Vulvovaginal conditions, symptoms, and how to deal with them, etc. Step 2 Change in vulvovaginal conditions before and after using the test sample, etc.
Key secondary outcomes	Step 1 Association of doctors' diagnosis and patients' feelings, and causal relationship with coping methods, etc. Step 2 Association of doctors' diagnosis and patients' feelings, etc.

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	Treatment
Type of intervention	Other
Interventions/Control_1	Testing the use of sanitary products
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	A regular visit to a gynecologist Patients presenting with a chief complaint of vulvar symptoms Women over 20 years old Consent has been obtained based on informed consent.
Key exclusion criteria	Not applicable
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Yutaka Middle name Last name Ueda
Organization	Graduate School of Medicine, Osaka University
Division name	Obstetrics and Gynecology
Zip code	565-0871
Address	2-2 Yamadaoka Suitashi, Osaka
TEL	06-6879-3351
Email	y.ueda@gyne.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Yutaka Middle name Last name Ueda
Organization	Graduate School of Medicine, Osaka University
Division name	Obstetrics and Gynecology
Zip code	565-0871
Address	2-2 Yamadaoka Suitashi, Osaka
TEL	06-6879-3351
Homepage URL
Email	y.ueda@gyne.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Unicharm
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka University Clinical Research Review Committee
Address	2-2 Yamadaoka Suitashi, Osaka
Tel	06-6210-8296
Email	rinri@hp-crc.med.osaka-u.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	2021 Year 06 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	Preinitiation
Date of protocol fixation	2021 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2023 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	2021 Year 05 Month 18 Day
Last modified on	2021 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050297