UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020909 |
|---|---|
| Receipt number | R000024124 |
| Scientific Title | Study of the efficacy of the hyaluronic acid preparations (hyaluprotect) for the atrophic changes due to aging in the vagina and vulva. |
| Date of disclosure of the study information | 2016/02/06 |
| Last modified on | 2019/02/08 11:08:26 |
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Basic information
Public title
Study of the efficacy of the hyaluronic acid preparations (hyaluprotect) for the atrophic changes due to aging in the vagina and vulva.
Acronym
Study of the efficacy of the hyaluprotect for the atrophic vagina due to aging.
Scientific Title
Study of the efficacy of the hyaluronic acid preparations (hyaluprotect) for the atrophic changes due to aging in the vagina and vulva.
Scientific Title:Acronym
Study of the efficacy of the hyaluprotect for the atrophic vagina due to aging.
Region
| Japan |
Condition
Condition
Atrophic changes due to aging of vagina and vulva.
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the efficasy of a hyaluronan product "hyaluprotect" to the atrophic changes due to aging of vagina and vulva.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sujjective symptoms and Vaginal Vestibule Maturation Value after 2,4 and 6 weeks.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A hyaluronic acid preparation (hyaluprotect)
2-4 weeks
Interventions/Control_2
estriol vaginal tablet
2-4 weeks
Interventions/Control_3
moistjelly
2-4 weeks
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
| 40 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Menopausal for more than six months due to physiological or surgical reason.
Complaint of dryness in the vagina.
Atrophic findings in the vulva.
Key exclusion criteria
No contraindication of estriol.
No bacterial infection.
No use of other external medication for vagina within one week.
No use of systemic estrogen within one month.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sakie Niwa |
Organization
Sakie ladies clinic
Division name
director
Zip code
Address
Hakubi Ikeshita Bild 3F 2-15 Ikeshita Chikusa Nagoya Japan
TEL
052-757-0222
info@tclinic.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mototsugu Fukaya |
Organization
Tsurumai Kouen Clinic
Division name
director
Zip code
Address
5-20-6 Chiyoda Nakaku Nagoya
TEL
052-164-0212
Homepage URL
moto@earth.ocn.ne.jp
Sponsor or person
Institute
Sakie ladies clinic
Institute
Department
Personal name
Funding Source
Organization
Fukaya corporation
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
Address
Tel
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
| 2016 | Year | 02 | Month | 06 | 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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 06 | 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
| 2016 | Year | 02 | Month | 06 | Day |
Last modified on
| 2019 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024124
