UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044912 |
|---|---|
| Receipt number | R000051295 |
| Scientific Title | Multicenter clinical study for intravaginal ejaculation disorder with use of a masturbation aid |
| Date of disclosure of the study information | 2021/07/20 |
| Last modified on | 2021/11/25 17:58:14 |
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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
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
masatos@juntendo-urayasu.jp
Sponsor or person
Institute
Juntendo University Urayasu Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051295
