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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031295
Receipt No. R000035726
Scientific Title A double-blind, placebo-controlled study with A-2 on symptoms of vaginal atrophy in postmenopausal women
Date of disclosure of the study information 2021/05/01
Last modified on 2018/02/14

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Basic information
Public title A double-blind, placebo-controlled study with A-2 on symptoms of vaginal atrophy in postmenopausal women
Acronym Effect of A-2 on symptoms of vaginal atrophy in postmenopausal women
Scientific Title A double-blind, placebo-controlled study with A-2 on symptoms of vaginal atrophy in postmenopausal women
Scientific Title:Acronym Effect of A-2 on symptoms of vaginal atrophy in postmenopausal women
Region
Japan

Condition
Condition Healthy postmenopausal women
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we investigate the symptoms of vaginal atrophy after ingestion of A-2 or placebo for 12 weeks in postmenopausal women.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The symptoms of vaginal atrophy after ingestion for 12 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 Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 1 time or 2 times/day, for 12 weeks
Interventions/Control_2 1 time or 2 times/day, for 12 weeks
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
45 years-old <=
Age-upper limit
65 years-old >
Gender Female
Key inclusion criteria 1) Duration of amenorrhea; >2 y and <5 y
2) Serum estradiol concentration; <21 pg/mL
3) Serum FSH concentration; >30 mIU/mL
4) The symptoms of vaginal atrophy
5) BMI; >18.5 and <30 kg/m2
6) No medication for menopausal symptoms
7) No OTC medical agents or health foods for relief of menopausal symptoms
Key exclusion criteria 1) Diversity from normal ranges of vital signs, and in clinical laboratory tests
2) Current or past reproductive-related cancer and so forth
3) Serious illumes
4) Allergies to soy or lactose
5) Individuals who are diagnosed as inappropriate for the trial by the principal Investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Takamatsu
Organization Department of Obstetrics and Gynecology, Tokyo Dental College Ichikawa General Hospital
Division name Professor
Zip code
Address 5-11-13, Sugano, Ichikawa-city, Chiba
TEL 047-322-0151
Email ktakamatsu@tdc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeto Uchiyama
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Saga Nutraceuthicals Research Institute
Zip code
Address 5006-5 Yoshinogari, Kanzaki-gun, Saga
TEL 0952-52-1522
Homepage URL
Email Uchiyama.Shigeto@otsuka.jp

Sponsor
Institute Department of Obstetrics and Gynecology, Tokyo Dental College Ichikawa General Hospital
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co., Ltd.
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
Email

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 05 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
2017 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 21 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
2018 Year 02 Month 14 Day
Last modified on
2018 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035726

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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