UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter clinical study for intravaginal ejaculation disorder with use of a masturbation aid
Acronym	clinical study for intravaginal ejaculation disorder with use of a masturbation aid
Scientific Title	Multicenter clinical study for intravaginal ejaculation disorder with use of a masturbation aid
Scientific Title:Acronym	clinical study for intravaginal ejaculation disorder with use of a masturbation aid
Region	Japan

Condition
Condition	intravaginal ejaculation disorder
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	intravaginal ejaculation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	intravaginal ejaculation
Key secondary outcomes	International Index of Erectile Function, EHS, Male Sexual Health Questionnaire for assessing ejaculatory dysfunction, Confidence in Performing Sexual Intercourse Questionnaire-12, Numerical Rating Scale

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	60 years-old >=
Gender	Male
Key inclusion criteria	bother with intravaginal ejaculation disorder one sexual partner continuing sexual intercourse
Key exclusion criteria	diabetes that is difficult to control neurogenic disease penile skin trouble
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Tsujimura
Organization	Juntendo University Urayasu Hospital
Division name	Department of Urology
Zip code	2790021
Address	2-1-1, Tomioka, Urayasu city, Chiba, Japan
TEL	+81473533111
Email	atsujimu@juntendo.ac.jp

Public contact
Name of contact person	1st name MASATO Middle name Last name SHIRAI
Organization	Juntendo University Urayasu Hospital
Division name	Department of Urology
Zip code	2790021
Address	2-1-1, Tomioka, Urayasu city, Chiba, Japan
TEL	+81473533111
Homepage URL
Email	masatos@juntendo-urayasu.jp

Sponsor
Institute	Juntendo University Urayasu Hospital
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Review Board, Juntendo University Urayasu Hospital
Address	2-1-1, Tomioka, Urayasu City, Chiba, Japan
Tel	+81-47-353-3111
Email	rinri-urayasu@juntendo-urayasu.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	順天堂大学浦安病院（千葉県）Juntendo University Urayasu Hospital 岩佐クリニック (大阪府) Iwasa clinic Dクリニック東京メンズヘルス（東京都）D clinic, Tokyo Men's

Other administrative information
Date of disclosure of the study information	2021 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	15
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	Completed
Date of protocol fixation	2020 Year 04 Month 14 Day
Date of IRB	2020 Year 04 Month 14 Day
Anticipated trial start date	2020 Year 04 Month 14 Day
Last follow-up date	2021 Year 11 Month 30 Day
Date of closure to data entry	2021 Year 11 Month 30 Day
Date trial data considered complete	2021 Year 11 Month 30 Day
Date analysis concluded	2021 Year 11 Month 30 Day

Other
Other related information	study duration is 2-month

Management information
Registered date	2021 Year 07 Month 20 Day
Last modified on	2021 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051295